FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME
Report
- Report Number
- 1037905-2013-00060
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Date of Event
- January 16, 2013
- Report Date
- January 16, 2013
- Manufacturer
- WILSON-COOK MEDICAL INC
- Product Code
- KNS
- PMA / PMN Number
- K052051
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
INVESTIGATION EVAL: TWO DEVICES WERE RETURNED TOGETHER IN AN OPEN POUCH THAT WAS LABELED CONTAMINATED - THESE DEVICES ARE LABELED AS #14 (MDR 1037905-2013-00060) AND #15 (MDR 1037905-2013-00061) FOR THE EVALUATION. TWELVE DEVICES WERE RECEIVED IN INDIVIDUAL OPEN POUCHES - THESE DEVICES ARE LABELED AS # 1, 2, 4-13 FOR THE EVAL. ONE SEALED DEVICE WAS RECEIVED - THIS DEVICE IS LABELED AS #3 FOR THE EVAL. THE LAB EVAL CONFIRMED THE COMPLAINT OF INCORRECT ORIENTATION FOR THE FOLLOWING DEVICES: 1, 2, 7, 9, 11, 14 AND 15. DEVICE #1: DURING THE VISUAL ANALYSIS IT WAS NOTED THAT THE CATHETER TIP AND CUTTING WIRE WAS INTACT AND DID NOT EXHIBIT SIGNS OF DEFORMATION. THE SHAPING WIRE WAS IN THE TIP OF THE RETURNED PRODUCT. TWISTING OF THE TUBING WAS NOT OBSERVED. DURING THE LAB ANALYSIS, THE SPHINCTEROTOME WAS ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-160V). THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING 12:00 O'CLOCK, HOWEVER BELOW THE PAPILLA. (APPROPRIATE ORIENTATION IS APPROXIMATELY 11:00 - 1:00 O'CLOCK). ACCESS TO THE PAPILLA WAS NOT ACHIEVABLE. ALTHOUGH NOT IN THE PAPILLA THE DEVICE WAS BOWED AND THE TIP AND THE CUTTING WIRE REMAINED FACING 12:00 O'CLOCK. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT WAS NOT OBSERVED DURING OUR LAB ANALYSIS. DEVICE #2: DURING THE VISUAL ANALYSIS, IT WAS NOTED THAT THE CATHETER TIP AND CUTTING WIRE WAS INTACT AND DID NOT EXHIBIT SIGNS OF DEFORMATION. THE SHAPING WIRE WAS IN THE TIP OF THE RETURNED PRODUCT. TWISTING OF THE TUBING WAS NOT OBSERVED. DURING THE LAB ANALYSIS, THE SPHINCTEROTOME WAS ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-160V). THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING 9:00 O'CLOCK, HOWEVER BELOW THE PAPILLA. (APPROPRIATE ORIENTATION IS APPROXIMATELY 11:00 - 1:00 O'CLOCK). (APPROPRIATE ORIENTATION IS APPROX 11:00 - 1:00 O'CLOCK). ACCESS TO THE PAPILLA WAS ACHIEVABLE BUT EXTREMELY DIFFICULT. THE DEVICE WAS BOWED AND THE TIP AND THE CUTTING WIRE REMAINED FACING 9:00 O'CLOCK. (APPROPRIATE ORIENTATION IS APPROX 11:00 - 1:00 O'CLOCK). DEVICE #3 - SEALED UNOPENED: DURING THE VISUAL ANALYSIS, IT WAS NOTED THAT THE CATHETER TIP AND CUTTING WIRE WAS INTACT AND DID NOT EXHIBIT SIGNS OF DEFORMATION. THE SHAPING WIRE WAS IN THE TIP OF THE RETURNED PRODUCT. TWISTING OF THE TUBING WAS NOT OBSERVED. DURING THE LAB ANALYSIS, THE SPHINCTEROTOME WAS ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-160V). THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING 12:00 O'CLOCK. THE DEVICE WAS THEN BOWED AND THE CUTTING WIRE REMAINED FACING 12:00 O'CLOCK. (APPROPRIATE ORIENTATION IS APPROX 11:00 - 1:00 O'CLOCK). A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT WAS NOT OBSERVED DURING OUR LAB ANALYSIS. DEVICE #4: DURING THE VISUAL ANALYSIS, IT WAS NOTED THAT THE CATHETER TIP AND CUTTING WIRE WAS INTACT AND DID NOT EXHIBIT SIGNS OF DEFORMATION. THE SHAPING WIRE WAS IN THE TIP OF THE RETURNED PRODUCT. TWISTING OF THE TUBING WAS NOT OBSERVED. DURING THE LAB ANALYSIS, THE SPHINCTEROTOME WAS ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-160V). THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING 11:00 O'CLOCK. THE DEVICE WAS THEN BOWED AND THE CUTTING WIRE REMAINED FACING 11:00 O'CLOCK. (APPROPRIATE ORIENTATION IS APPROX 11:00 - 1:00 O'CLOCK). A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT WAS NOT OBSERVED DURING OUR LAB ANALYSIS. DEVICE #5: DURING THE VISUAL ANALYSIS, IT WAS NOTED THAT THE CATHETER TIP AND CUTTING WIRE WAS INTACT AND DID NOT EXHIBIT SIGNS OF DEFORMATION. THE SHAPING WIRE WAS IN THE TIP OF THE RETURNED PRODUCT. TWISTING OF THE TUBING WAS NOT OBSERVED. DURING THE LAB ANALYSIS, THE SPHINCTEROTOME WAS ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-160V). THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING 11:00 O'CLOCK. THE DEVICE WAS THEN BOWED AND THE CUTTING WIRE REMAINED FACING 11:00 O'CLOCK. (APPROPRIATE ORIENTATION IS APPROX 11:00 - 1:00 O'CLOCK). A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT WAS NOT OBSERVED DURING OUR LAB ANALYSIS. DEVICE #6: DURING THE VISUAL ANALYSIS, IT WAS NOTED THAT THE CATHETER TIP AND CUTTING WIRE WAS INTACT AND DID NOT EXHIBIT SIGNS OF DEFORMATION. THE SHAPING WIRE WAS IN THE TIP OF THE RETURNED PRODUCT. TWISTING OF THE TUBING WAS NOT OBSERVED. DURING THE LAB ANALYSIS, THE SPHINCTEROTOME WAS ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-160V). THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING 11:00 O'CLOCK. THE DEVICE WAS THEN BOWED AND THE CUTTING WIRE REMAINED FACING 11:00 O'CLOCK. (APPROPRIATE ORIENTATION IS APPROX 11:00 - 1:00 O'CLOCK). A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT WAS NOT OBSERVED DURING OUR LAB ANALYSIS. DEVICE #7: DURING THE VISUAL ANALYSIS, IT WAS NOTED THAT THE CATHETER TIP AND CUTTING WIRE WAS INTACT AND DID NOT EXHIBIT SIGNS OF DEFORMATION. THE SHAPING WIRE WAS IN THE TIP OF THE RETURNED PRODUCT. TWISTING OF THE TUBING WAS NOT OBSERVED. DURING THE LAB ANALYSIS, THE SPHINCTEROTOME WAS ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-160V). THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING 3:00 O'CLOCK. (APPROPRIATE ORIENTATION IS APPROX 11:00 - 1:00 O'CLOCK). ACCESS TO THE PAPILLA WAS NOT ACHIEVABLE. ALTHOUGH NOT IN THE PAPILLA, THE DEVICE WAS BOWED AND THE TIP AND THE CUTTING WIRE TWISTED AND WAS FACING 2:00 O'CLOCK. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT WAS NOT OBSERVED DURING OUR LAB ANALYSIS. DEVICE #8: DURING THE VISUAL ANALYSIS, IT WAS NOTED THAT THE CATHETER TIP AND CUTTING WIRE WAS INTACT AND DID NOT EXHIBIT SIGNS OF DEFORMATION. THE SHAPING WIRE WAS IN THE TIP OF THE RETURNED PRODUCT. TWISTING OF THE TUBING WAS NOT OBSERVED. DURING THE LAB ANALYSIS, THE SPHINCTEROTOME WAS ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-160V). THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING 11:00 O'CLOCK. THE DEVICE WAS THEN BOWED AND THE CUTTING WIRE REMAINED FACING 11:00 O'CLOCK. (APPROPRIATE ORIENTATION IS APPROX 11:00 - 1:00 O'CLOCK). A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT WAS NOT OBSERVED DURING OUR LAB ANALYSIS. DEVICE #9: DURING THE VISUAL ANALYSIS, IT WAS NOTED THAT THE CATHETER TIP AND CUTTING WIRE WAS INTACT AND DID NOT EXHIBIT SIGNS OF DEFORMATION. THE SHAPING WIRE WAS IN THE TIP OF THE RETURNED PRODUCT. TWISTING OF THE TUBING WAS NOT OBSERVED. DURING THE LAB ANALYSIS, THE SPHINCTEROTOME WAS ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-160V). THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING 3:00 O'CLOCK. (APPROPRIATE ORIENTATION IS APPROX 11:00 - 1:00 O'CLOCK). ACCESS TO THE PAPILLA WAS NOT ACHIEVABLE. ALTHOUGH NOT IN THE PAPILLA, THE DEVICE WAS BOWED AND THE TIP AND THE CUTTING WIRE TWISTED AND WAS FACING 12:00 O'CLOCK. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT WAS NOT OBSERVED DURING OUR LAB ANALYSIS. DEVICE #10: DURING THE VISUAL ANALYSIS, IT WAS NOTED THAT THE CATHETER TIP AND CUTTING WIRE WAS INTACT AND DID NOT EXHIBIT SIGNS OF DEFORMATION. THE SHAPING WIRE WAS IN THE TIP OF THE RETURNED PRODUCT. TWISTING OF THE TUBING WAS NOT OBSERVED. DURING THE LAB ANALYSIS, THE SPHINCTEROTOME WAS ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-160V). THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING 11:00 O'CLOCK. THE DEVICE WAS THEN BOWED AND THE CUTTING WIRE REMAINED FACING 11:00 O'CLOCK. (APPROPRIATE ORIENTATION IS APPROX 11:00 - 1:00 O'CLOCK). A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT WAS NOT OBSERVED DURING OUR LAB ANALYSIS. DEVICE #11: DURING THE VISUAL ANALYSIS, IT WAS NOTED THAT THE CATHETER TIP AND CUTTING WIRE WAS INTACT AND DID NOT EXHIBIT SIGNS OF DEFORMATION. THE SHAPING WIRE WAS IN THE TIP OF THE RETURNED PRODUCT. TWISTING OF THE TUBING WAS NOT OBSERVED. DURING THE LAB ANALYSIS, THE SPHINCTEROTOME WAS ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-160V). THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING 10:00 O'CLOCK. (APPROPRIATE ORIENTATION IS APPROX 11:00 - 1:00 O'CLOCK). ACCESS TO THE PAPILLA WAS ACHIEVABLE BUT EXTREMELY DIFFICULT. THE DEVICE WAS BOWED AND THE TIP AND THE CUTTING WIRE REMAINED FACING 10:00 O'CLOCK. (APPROPRIATE ORIENTATION IS APPROX 11:00 - 1:00 O'CLOCK). DEVICE #12: DURING THE VISUAL ANALYSIS, IT WAS NOTED THAT THE CATHETER TIP AND CUTTING WIRE WAS INTACT AND DID NOT EXHIBIT SIGNS OF DEFORMATION. THE SHAPING WIRE WAS IN THE TIP OF THE RETURNED PRODUCT. TWISTING OF THE TUBING WAS NOT OBSERVED. DURING THE LAB ANALYSIS, THE SPHINCTEROTOME WAS ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-160V). THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING 11:00 O'CLOCK. THE DEVICE WAS THEN BOWED AND THE CUTTING WIRE REMAINED FACING 11:00 O'CLOCK. (APPROPRIATE ORIENTATION IS APPROX 11:00 - 1:00 O'CLOCK). A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT WAS NOT OBSERVED DURING OUR LAB ANALYSIS. DEVICE #13: DURING THE VISUAL ANALYSIS, IT WAS NOTED THAT THE CATHETER TIP AND CUTTING WIRE WAS INTACT AND DID NOT EXHIBIT SIGNS OF DEFORMATION. THE SHAPING WIRE WAS IN THE TIP OF THE RETURNED PRODUCT. TWISTING OF THE TUBING WAS NOT OBSERVED. DURING THE LAB ANALYSIS, THE SPHINCTEROTOME WAS ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-160V). THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING 11:00 O'CLOCK. THE DEVICE WAS THEN BOWED AND THE CUTTING WIRE REMAINED FACING 11:00 O'CLOCK. (APPROPRIATE ORIENTATION IS APPROX 11:00 - 1:00 O'CLOCK). A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT WAS NOT OBSERVED DURING OUR LAB ANALYSIS. DEVICE #14: DURING THE VISUAL ANALYSIS, IT WAS NOTED THAT THE CATHETER TIP AND CUTTING WIRE WAS INTACT AND DID NOT EXHIBIT SIGNS OF DEFORMATION. THE SHAPING WIRE WAS IN THE TIP OF THE RETURNED PRODUCT. TWISTING OF THE TUBING WAS NOT OBSERVED. DURING THE LAB ANALYSIS, THE SPHINCTEROTOME WAS ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-160V). THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING 10:00 O'CLOCK. (APPROPRIATE ORIENTATION IS APPROX 11:00 - 1:00 O'CLOCK). ACCESS TO THE PAPILLA WAS ACHIEVABLE BUT EXTREMELY DIFFICULT. THE DEVICE WAS BOWED AND THE TIP AND THE CUTTING WIRE REMAINED FACING 10:00 O'CLOCK. (APPROPRIATE ORIENTATION IS APPROX 11:00 - 1:00 O'CLOCK). THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSIONS: A DEFINITIVE CAUSE FOR THE OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS AND THE TESTING OF THE PRIOR TO USE DEVICES COULD NOT BE DUPLICATED IN THE LAB SETTING. FOR THE USED PRODUCTS: DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATES, WER COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LAB ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. IMPROPER CUTTING WIRE ORIENTATION CAN OCCUR IF THE DISTAL END OF THE CATHETER IS SHAPED MANUALLY. THIS SPHINCTEROTOME CATHETER IS PRECURVED AND IS PROVIDED WITH A PRECURVED STYLET IN THE DISTAL TIP OF THE CATHETER. THIS OBVIATES THE NEED FOR MANUAL FORMATION. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING COMMENT: "NOTE: DO NOT APPLY MANUAL PRESSURE TO TIP OR CUTTING WIRE OF THE SPHINCTEROTOME TO INFLUENCE ORIENTATION, AS THIS MAY RESULT IN DAMAGE TO DEVICE." OTHER FACTORS THAT CAN CONTRIBUTE TO IMPROPER CUTTING WIRE ORIENTATION INCLUDE MANIPULATING THE HANDLE WITH THE CATHETER IN A COILED POSITION OR WITH THE PRECURVED STYLET INSIDE THE CANNULATING TIP. THE INSTRUCTIONS FOR USE ADVISE THE USER TO UNCOIL AND STRAIGHTEN THE SPHINCTEROTOME UPON REMOVING THE DEVICE FROM THE PACKAGING. THE USER IS THEN INSTRUCTED TO CAREFULLY REMOVE THE PRECURVED STYLET FROM THE CANNULATING TIP. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING COMMENT: "NOTE: DO NOT EXERCISE HANDLE WHILE DEVICE IS COILED OR PRECURVED STYLET IS IN PLACE, AS THIS MAY CAUSE DAMGE TO SPHINCTEROTOME AND RENDER IT INOPERABLE." PRIOR TO DISTRIBUTION, ALL FUSION OMNI-TOME SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.
DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME WAS USED. THE SPHINCTEROTOME EXITED THE ENDOSCOPE WITH THE CUTTING WIRE IN THE 8 TO 9 O'CLOCK POSITION. THE DEVICE WAS IMPOSSIBLE TO USE. ANOTHER TOME WAS USED TO FINISH THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 66962 | FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME | KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES | KNS | WILSON-COOK MEDICAL INC | W3221815 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MET-35-260 WIREGUIDE| FS-WL-P-S WIRELOCK| PENTAX DUODENOSCOPE (UNK MODEL NUMBER) |