FUSION CYTOLOGY BRUSH
Report
- Report Number
- 1037905-2024-00714
- Event Type
- Malfunction
- Date Received
- November 12, 2024
- Date of Event
- October 1, 2024
- Report Date
- December 12, 2024
- Manufacturer
- WILSON-COOK MEDICAL INC
- Product Code
- FDX
- UDI-DI
- 10827002315256
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PMA/510(K): K192908. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.
INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS PERFORMED ONLY BY THE PICTURES PROVIDED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT WAS CONFIRMED WITH THE PICTURES PROVIDED. THE FIRST PICTURE IS AN "INTACT CYTOLOGY BRUSH TO SEE THE DIFFERENCE" PROVIDED BY THE USER. THE SECOND PICTURE SHOWS BRUSH PORTION OF THE PRODUCT SAID TO BE INVOLVED, AND THE COIL SPRING HAS DETACHED. THE DETACHED COIL SPRING IS NOT IN THE PICTURE. A PICTURE OF THE LOT NUMBER WAS NOT PROVIDED. WITHOUT THE PRODUCT OR SUBSTANTIAL EVIDENCE TO CONTRADICT THE COMPLAINT, IT IS CONSIDERED CONFIRMED BASED SOLELY ON THE PHOTOS PROVIDED AND STATEMENTS DESCRIBING THE EVENT. 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: OUR EVALUATION OF THE PICTURES PROVIDED CONFIRMED THE REPORT. A CORRECTIVE ACTION (CAPA) HAS BEEN INITIATED TO REDUCE OCCURRENCES OF BRUSH TIP/COIL SPRING DETACHMENT FOR CYTOLOGY BRUSH DEVICES. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTIONS. PRIOR TO DISTRIBUTION, ALL FUSION CYTOLOGY BRUSHES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE POSSIBLE DEVICE HISTORY RECORDS CONFIRMED THAT THE LOTS 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. A CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS MANUFACTURED INCLUDED IN THE SCOPE OF THIS CORRECTIVE ACTION. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.
INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS PERFORMED ONLY BY THE PICTURES PROVIDED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT WAS CONFIRMED WITH THE PICTURES PROVIDED. THE FIRST PICTURE IS AN "INTACT CYTOLOGY BRUSH TO SEE THE DIFFERENCE" PROVIDED BY THE USER. THE SECOND PICTURE SHOWS BRUSH PORTION OF THE PRODUCT SAID TO BE INVOLVED, AND THE COIL SPRING HAS DETACHED. THE DETACHED COIL SPRING IS NOT IN THE PICTURE. A PICTURE OF THE LOT NUMBER WAS NOT PROVIDED. WITHOUT THE PRODUCT OR SUBSTANTIAL EVIDENCE TO CONTRADICT THE COMPLAINT, IT IS CONSIDERED CONFIRMED BASED SOLELY ON THE PHOTOS PROVIDED AND STATEMENTS DESCRIBING THE EVENT. 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: OUR EVALUATION OF THE PICTURES PROVIDED CONFIRMED THE REPORT. A CORRECTIVE ACTION (CAPA) HAS BEEN INITIATED TO REDUCE OCCURRENCES OF BRUSH TIP/COIL SPRING DETACHMENT FOR CYTOLOGY BRUSH DEVICES. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTIONS. PRIOR TO DISTRIBUTION, ALL FUSION CYTOLOGY BRUSHES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE POSSIBLE DEVICE HISTORY RECORDS CONFIRMED THAT THE LOTS SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A CORRECTIVE ACTION (CAPA) WAS INITIATED TO FURTHER INVESTIGATE DEVICE FAILURE DUE TO BRUSH TIP/COIL SPRING DETACHMENT . THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTION. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.
DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN USED A COOK FUSION CYTOLOGY BRUSH. IT WAS REPORTED THAT A CYTOLOGY BRUSH WAS USED IN PROCEDURE AND AFTER PLACEMENT OF A PLASTIC STENT, AN X-RAY WAS DONE TO CONFIRM POSITION OF PLASTIC STENT. IT WAS NOTED THAT A VERY SMALL PIECE OF BRUSH TIP WAS MISSING [DETACHED]. A PHOTO OF THE DEVICE WAS PROVIDED AND THE DISTAL TIP IS DETACHED. AT THE TIME OF THIS REPORT, OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME HAVE BEEN UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR HOW DETACHED DEVICE PORTION WAS RETRIEVED, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED. ADDITIONAL ATTEMPTS TO GATHER THIS INFORMATION WILL BE MADE.
DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN USED A COOK FUSION CYTOLOGY BRUSH. IT WAS REPORTED THAT A CYTOLOGY BRUSH WAS USED IN PROCEDURE AND AFTER PLACEMENT OF A PLASTIC STENT, AN X-RAY WAS DONE TO CONFIRM POSITION OF PLASTIC STENT. IT WAS NOTED THAT A VERY SMALL PIECE OF BRUSH TIP WAS MISSING [DETACHED]. A PHOTO OF THE DEVICE WAS PROVIDED AND THE DETACHED COIL SPRING IS NOT IN THE PICTURE. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. THE COMPLAINANT STATED THAT THEY PLACED A STENT TO ENSURE THE PATIENT WAS ABLE TO DRAIN BILE, WHICH COULD INDICATE THAT THE DETACHED PORTION WAS LEFT TO PASS NATURALLY, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.
DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN USED A COOK FUSION CYTOLOGY BRUSH. IT WAS REPORTED THAT A CYTOLOGY BRUSH WAS USED IN PROCEDURE AND AFTER PLACEMENT OF A PLASTIC STENT, AN X-RAY WAS DONE TO CONFIRM POSITION OF PLASTIC STENT. IT WAS NOTED THAT A VERY SMALL PIECE OF BRUSH TIP WAS MISSING [DETACHED]. A PHOTO OF THE DEVICE WAS PROVIDED AND THE DISTAL TIP IS DETACHED. THE DETACHED PORTION OF THE CYTOLOGY BRUSH TIP REMAINED IN THE PATIENT'S BILIARY DUCT. FURTHER ERCP WAS PERFORMED AND ATTEMPTED RETRIEVAL WAS UNSUCCESSFUL. A STENT WAS PLACED TO ENSURE THE PATIENT WAS ABLE TO DRAIN BILE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1136056 | FUSION CYTOLOGY BRUSH | FDX ENDOSCOPIC CYTOLOGY BRUSH | FDX | WILSON-COOK MEDICAL INC | G31525 | W4794756 | 10827002315256 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other | UNKNOWN ENDOSCOPE |