FUSION OMNI-TOME
Report
- Report Number
- 1037905-2023-00459
- Event Type
- Injury
- Date Received
- September 26, 2023
- Date of Event
- August 30, 2023
- Report Date
- October 24, 2023
- Manufacturer
- WILSON-COOK MEDICAL INC
- Product Code
- KNS
- UDI-DI
- 10827002319032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PMA/510(K) # K172288. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS PERFORMED ONLY BY THE PICTURE PROVIDED WITH THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. A PHOTO OF THE LOT NUMBER WAS NOT PROVIDED. THE PROVIDED PHOTO SHOWS THE DISTAL END OF THE DEVICE. A RED SUBSTANCE WAS PRESENT WITHIN THE DISTAL CATHETER AND THE CUTTING WIRE APPEARS TO REMAIN ATTACHED AT BOTH ENDS. HOWEVER, THE PHOTO IS SLIGHTLY BLURRED PREVENTING A COMPLETE VISUAL INSPECTION OF THE CUTTING WIRE AND SECURING COMPONENT. PER THE PHOTO PROVIDED WE CANNOT COMPLETE A FULL EVALUATION. THEREFORE, THE PHOTO IS INCONCLUSIVE AND THE REPORT COULD NOT BE CONFIRMED. 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 CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. THE PROVIDED PHOTO WAS INCONCLUSIVE, THEREFORE A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. 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: "DO NOT OVER FLEX OR BOW THE TIP BEYOND 90 DEGREES, AS THIS MAY DAMAGE OR CAUSE THE CUTTING WIRE TO BREAK." 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 PRECURVED STYLET INSIDE THE CANNULATING TIP. THE INSTRUCTIONS FOR USE ADVISE THE USER: "UPON REMOVING THE DEVICE FROM THE PACKAGE, UNCOIL AND STRAIGHTEN THE SPHINCTEROTOME. CAREFULLY REMOVE THE PRECURVED STYLET FROM THE CANNULATING TIP." THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING COMMENT: "DO NOT EXERCISE THE HANDLE WHILE THE DEVICE IS COILED OR THE PRECURVED STYLET IS IN PLACE, AS THIS MAY CAUSE DAMAGE TO THE SPHINCTEROTOME AND RENDER IT INOPERABLE." PRIOR TO DISTRIBUTION, ALL FUSION OMNI-TOME SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. 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.
PMA/510(K) # K172288. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS PERFORMED ONLY BY THE PICTURE PROVIDED WITH THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. A PHOTO OF THE LOT NUMBER WAS NOT PROVIDED. THE PROVIDED PHOTO SHOWS THE DISTAL END OF THE DEVICE. A RED SUBSTANCE WAS PRESENT WITHIN THE DISTAL CATHETER AND THE CUTTING WIRE APPEARS TO REMAIN ATTACHED AT BOTH ENDS. HOWEVER, THE PHOTO IS SLIGHTLY BLURRED PREVENTING A COMPLETE VISUAL INSPECTION OF THE CUTTING WIRE. PER THE PHOTO PROVIDED WE CANNOT COMPLETE A FULL EVALUATION. THEREFORE, THE PHOTO IS INCONCLUSIVE FOR DAMAGE TO THE CUTTING WIRE. THE REPORT COULD NOT BE CONFIRMED. 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 CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. DAMAGE TO THE CUTTING WIRE CAN OCCUR IF THE TIP OF THE SPHINCTEROTOME IS OVER FLEXED. THE INSTRUCTIONS FOR USE CAUTION THE USER WITH THE FOLLOWING COMMENT: ¿DO NOT OVER FLEX OR BOW THE TIP BEYOND 90 DEGREES, AS THIS MAY DAMAGE OR CAUSE THE CUTTING WIRE TO BREAK.¿ OTHER FACTORS THAT CAN CAUSE DAMAGE TO THE CUTTING WIRE INCLUDE MANIPULATING THE HANDLE WITH THE CATHETER IN A COILED POSITION OR WITH THE PRECURVED STYLET INSIDE THE CANNULATING TIP. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING PRECAUTION: "DO NOT EXERCISE THE HANDLE WHILE THE DEVICE IS COILED OR THE PRECURVED STYLET IS IN PLACE, AS THIS MAY CAUSE DAMAGE TO THE SPHINCTEROTOME AND RENDER IT INOPERABLE." THE INSTRUCTIONS FOR USE ADVISE THE USER WITH THE FOLLOWING STATEMENT: ¿UPON REMOVING THE DEVICE FROM THE PACKAGE, UNCOIL AND STRAIGHTEN SPHINCTEROTOME. CAREFULLY REMOVE THE PRECURVED STYLET FROM THE CANNULATING TIP.¿ PRIOR TO DISTRIBUTION, ALL FUSION OMNI-TOME SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THE VISUAL INSPECTION ENSURES THE PRODUCT IS FREE OF KINKS. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN ISOLATED OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED REMOTE. 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) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME. IT WAS REPORTED THAT THE CUTTING WIRE DETACHED FROM THE SPHINCTEROTOME. THE PATIENT HAD A BLEEDING EVENT, THE PHYSICIAN AND TEAM AREN¿T SURE IF IT WAS CAUSED FROM THE CUTTING WIRE DETACHING OR NOT. THE PHYSICIAN AND TEAM USED A VIABIL METAL FULLY COVERED STENT TO STOP THE BLEEDING. THE PROCEDURE WAS COMPLETED BY USING ANOTHER OF THE SAME DEVICE, JUST A DIFFERENT LOT NUMBER. PER FURTHER INFORMATION RECEIVED ON 12 SEP 2023: THE PHYSICIAN PLACED THE STENT DUE TO THE BLEEDING CAUSED BY THE SPHINCTEROTOMY. THE BLEEDING WAS IN THE BILIARY ORIFICE. PER FURTHER INFORMATION RECEIVED ON 27 SEP 2023: THE "T" PART OF THE CUTTING WIRE THAT IS NORMALLY INSIDE THE DEVICE HAD COME OUT [CUTTING WIRE SECURING COMPONENT/ANCHOR SEPARATION] AND THE DOCTOR WAS NOT SURE IF THAT WAS THE REASON FOR THE BLEEDING EVENT." A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT EXPERIENCED A BLEEDING EVENT AND REQUIRED VIABIL METAL FULLY COVERED STENT TO STOP THE BLEEDING DUE TO THIS OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED BY THE INITIAL REPORTER.
DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME. IT WAS REPORTED THAT THE CUTTING WIRE DETACHED FROM THE SPHINCTEROTOME. THE PATIENT HAD A BLEEDING EVENT, THE PHYSICIAN AND TEAM AREN¿T SURE IF IT WAS CAUSED FROM THE CUTTING WIRE DETACHING OR NOT. THE PHYSICIAN AND TEAM USED A VIABIL METAL FULLY COVERED STENT TO STOP THE BLEEDING. THE PROCEDURE WAS COMPLETED BY USING ANOTHER OF THE SAME DEVICE, JUST A DIFFERENT LOT NUMBER. PER FURTHER INFORMATION RECEIVED ON (B)(6) 2023: THE PHYSICIAN PLACED THE STENT DUE TO THE BLEEDING CAUSED BY THE SPHINCTEROTOMY. THE BLEEDING WAS IN THE BILIARY ORIFICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT EXPERIENCED A BLEEDING EVENT AND REQUIRED VIABIL METAL FULLY COVERED STENT TO STOP THE BLEEDING DUE TO THIS OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED BY THE INITIAL REPORTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 973613 | FUSION OMNI-TOME | KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | WILSON-COOK MEDICAL INC | W4745399 | 10827002319032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention | ERBE VIO ELECTROSURGICAL GENERATOR| OLYMPUS 190 ENDOSCOPE| OLYMPUS VISIGLIDE 025 WIRE GUIDE |