FUSION OMNI-TOME SPHINCTEROTOME
Report
- Report Number
- 1037905-2010-00630
- Event Type
- Malfunction
- Date Received
- November 19, 2010
- Date of Event
- September 21, 2010
- Report Date
- October 20, 2010
- Manufacturer
- COOK ENDOSCOPY
- Product Code
- KNS
- PMA / PMN Number
- K052051
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
THE INFO IN THIS REPORT WAS PROVIDED TO US BY THE COOK FACILITY IN (B)(6) ON BEHALF OF A MEDICAL FACILITY IN (B)(6). (B)(6). ON (B)(6) 2010, THE DEVICE WAS RETURNED FOR EVAL. UPON EVAL, WE CONFIRMED THE CUTTING WIRE TO BE INTACT. HOWEVER, THE CUTTING WIRE SECURING COMPONENT LOCATED AT THE DISTAL END OF THE CUTTING WIRE DISCONNECTED FROM THE SPHINCTEROTOME CATHETER. A SECTION OF THE CUTTING WIRE SECURING COMPONENT (APPROX 3 MM IN LENGTH AND 0.5 MM IN DIAMETER) HAS BROKEN AND DETACHED FROM THE DEVICE. THE INITIAL REPORTER INDICATED NO SECTION OF THE DEVICE REMAINED INSIDE THE PT'S BODY. OUR LAB RESULTS WERE COMMUNICATED TO THE INITIAL REPORTER. IF ADD'L INFO IS PROVIDED, A F/U MEDWATCH REPORT WILL BE SUBMITTED. ACCORDING TO THE INITIAL REPORTER, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. EVAL: OUR LAB EVAL OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE CUTTING WIRE SECURING COMPONENT LOCATED NEAR THE DISTAL END OF THE SPHINCTEROTOME HAS DISCONNECTED FROM THE CATHETER. THE CUTTING WIRE IS INTACT AND REMAINS SECURELY ATTACHED TO THE SPHINCTEROTOME AT THE PROXIMAL END. HOWEVER, DUE TO THE CATHETER AND SECURING COMPONENT DISCONNECTION, THE DISTAL END OF THE CUTTING WIRE IS NO LONGER CONNECTED TO THE SPHINCTEROTOME CATHETER AT THE DISTAL END. A SECTION OF THE CUTTING WIRE SECURING COMPONENT HAS BROKEN AND DETACHED FROM THE DEVICE. THE BROKEN SECTION IS ESTIMATED TO BE 3 MM IN LENGTH AND 0.5 MM IN DIAMETER. THE BROKEN SECTION WAS NOT INCLUDED IN THE RETURN. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PRODUCT SAID TO BE INVOLVED WAS CONDUCTED. DURING THE MFG PROCESS, 1 PRODUCT FROM THIS LOT WAS SCRAPPED FOR SPLIT/SEVERED. THE PRODUCT WAS SCRAPPED BEFORE RELEASING THIS LOT OF PRODUCT FOR DISTRIBUTION; THEREFORE, REJECTS WERE NOT IDENTIFIED FOR THE PRODUCTS IN THIS LOT THAT WERE DISTRIBUTED FOR USE. THE APPROPRIATE PERSONNEL WERE INFORMED OF THIS OBSERVATION IN AN EFFORT TO HEIGHTEN AWARENESS. CUSTOMER QA WILL MONITOR FOR TRENDS. A REVIEW OF THE 12 MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. CONCLUSIONS: SEPARATION OF THE CUTTING WIRE SECURING COMPONENT AND THE CATHETER CAN OCCUR IF THE TIP OF THE SPHINCTEROTOME IS OVER FLEXED. THE INSTRUCTIONS FOR USE CAUTION THE USER NOT TO OVER FLEX OR BOW THE TIP BEYOND 90 DEGREES, AS THIS MAY DAMAGE THE SPHINCTEROTOME. THIS TYPE OF DAMAGE CAN OCCUR IF THE DISTAL END OF THE CATHETER IS SHAPED MANUALLY. THIS SPHINCTEROTOME CATHETER IS PRE-CURVED AND IS PROVIDED WITH A PRE-CURVED 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." IF THE ELEVATOR OF THE ENDOSCOPE REMAINS IN THE CLOSED/UP POSITION WHEN RETRACTION OF THE SPHINCTEROTOME IS ATTEMPTED AND ADD'L PRESSURE IS APPLIED, THIS COULD HAVE CONTRIBUTED TO SEPARATION OF THE CATHETER AND CUTTING WIRE SECURING COMPONENT. THE INSTRUCTIONS FOR USE CAUTION THE USER, THE ELEVATOR SHOULD REMAIN OPEN/DOWN WHEN ADVANCING OR RETRACTING THE SPHINCTEROTOME. THIS ACTIVITY WILL AID IN DEVICE PRESERVATION. OTHER FACTORS THAT CAN CONTRIBUTE TO SEPARATION OF THE CUTTING WIRE SECURING COMPONENT AND THE CATHETER INCLUDE MANIPULATING THE HANDLE WITH THE CATHETER IN A COILED POSITION OR WITH THE PRE-CURVED 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 PRE-CURVED STYLET FROM THE CANNULATING TIP. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING COMMENT: "NOTE: DO NOT EXERCISE HANDLE WHILE DEVICE IS COILED OR PRE-CURVED STYLET IS IN PLACE, AS THIS MAY CAUSE DAMAGE 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. THE FUNCTIONAL TEST INCLUDES BOWING THE SPHINCTEROTOME TO ENSURE THE DISTAL END RESPONDS TO HANDLE MANIPULATION. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTIONS: A CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS MFG PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QA WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.
ON (B)(6) 2010, THE FOLLOWING INFO WAS PROVIDED TO COOK ENDOSCOPY: DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ENDOSCOPY FUSION OMNI-TOME SPHINCTEROTOME. WHEN CAUTERY WAS APPLIED TO PERFORM THE SPHINCTEROTOMY, THE SPHINCTEROTOME CUTTING WIRE REPORTEDLY BROKE. THIS INFO DID NOT REASONABLY SUGGEST A REPORTABLE EVENT HAD OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FUSION OMNI-TOME SPHINCTEROTOME | KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES | KNS | COOK ENDOSCOPY | W2786034 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ACTIVE CORD (UNK TYPE)| ENDOSCOPE (UNK TYPE)| ERBE ELECTROSURGICAL UNIT |