HEMOSPRAY ENDOSCOPIC HEMOSTAT
Report
- Report Number
- 1037905-2024-00166
- Event Type
- Malfunction
- Date Received
- March 20, 2024
- Date of Event
- March 12, 2024
- Report Date
- September 23, 2024
- Manufacturer
- WILSON-COOK MEDICAL INC
- Product Code
- QAU
- UDI-DI
- 00827002246638
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PMA/510(K) # K200972. THE INVESTIGATION IS ONGOING. A FOLLOW-UP EMDR WILL BE SUBMITTED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.
510(K): K200972. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. A PHOTO OF THE PRODUCT LABEL WAS PROVIDED. THE LOT NUMBER ON THE LABEL MATCHES THE REPORTED LOT. 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. A CORRECTIVE ACTION (CAPA) WAS INITIATED TO FURTHER INVESTIGATE DEVICE FAILURE DUE TO BEING UNABLE TO SPRAY POWDER. THIS DEVICE IS WITHIN THE SCOPE OF THE CAPA. PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING 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 CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS 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.
PMA/510(K) # K200972. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A CLEAR PLASTIC BAG, PROVIDED WITH THE RETURN WAS AN OPEN TRAY FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. A PHOTO OF THE PRODUCT LABEL WAS PROVIDED. THE LOT NUMBER ON THE LABEL MATCHES THE REPORTED LOT. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. NOT ALL COMPONENTS WERE INCLUDED IN THE RETURN (ONLY 1 CATHETER WAS RETURNED). A LARGE BUILD UP OF POWDER WAS NOTED WITHIN THE CATHETER. THE DEVICE WAS RETURNED WITH THE ON/OFF SWITCH IN THE "OFF" POSITION. THE RED ACTIVATION KNOB WAS DISENGAGED IN THE HANDLE INDICATING DEACTIVATION OF THE CARBON DIOXIDE (CO2) CARTRIDGE. THE CO2 CARTRIDGE WAS FULLY PUNCTURED. THE FOAM INSERT WAS PRESENT AND CORRECTLY ORIENTED INSIDE THE DEVICE. A VISUAL EXAMINATION OF THE O-RING AND LANCE INSIDE THE HANDLE SHOWED BOTH COMPONENTS TO BE POSITIONED CORRECTLY INSIDE THE HANDLE AND THE LANCE TO BE BEVELED. THE INSPECTION OF THE CO2 CARTRIDGE AND REGULATOR (LANCE AND O-RING) CONFIRM THE DEVICE WAS OF THE CURRENT DESIGN. WHEN TESTED WITH A NEW CO2 CARTRIDGE AND A NEW ACTIVATION KNOB, THE DEVICE SPRAYED POWDER AS INTENDED WITH A SOFT INTERMITTENT TICKING SOUND NOTED WHILE IDLE. THE RETURNED CATHETER WAS ATTACHED AND TESTED WITH THE RETURNED DEVICE. WHEN ATTEMPTING TO SPRAY, POWDER WAS OBSERVED EXITING THE NOZZLE AND MOVING THROUGH THE CATHETER UNTIL REACHING THE ACCUMULATED POWDER IN THE CATHETER CONFIRMING THE CATHETER HAS BECOME OCCLUDED. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. 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 RETURNED DEVICE CONFIRMED THE REPORT OF CLOGGED CATHETER. WHILE THE DEVICE WAS ABLE TO SPRAY POWDER AS INTENDED WITH A NEW CO2 CARTRIDGE AND ACTIVATION KNOB WITHOUT THE RETURNED CATHETER, POWDER WAS NOT ABLE TO PASS THROUGH THE CATHETER WHEN IT WAS ATTACHED. A DEFINITIVE CAUSE FOR THE OCCLUDED CATHETER COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. CATHETER OCCLUSION/CLOGGING CAN BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE. TO ASSIST THE USER, THE INSTRUCTIONS FOR USE STATE THE FOLLOWING, "DO NOT TEST DEVICE PRIOR TO INSERTION INTO ENDOSCOPE ACCESSORY CHANNEL AS THIS MAY INCREASE RISK OF CATHETER OCCLUSION." THE INSTRUCTIONS FOR USE ALSO STATES, "PRECAUTION: TO AVOID CATHETER OCCLUSION, DO NOT PLACE CATHETER DIRECTLY IN CONTACT WITH BLOOD AND/OR MUCOSA, INCLUDING ANY POOLED BLOOD AND DO NOT ASPIRATE BLOOD WHILE CATHETER IS IN ACCESSORY CHANNEL." PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING 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: 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) # K200972. THE INVESTIGATION IS ONGOING. A FOLLOW-UP EMDR WILL BE SUBMITTED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.
THIS FOLLOW UP EMDR IS BEING SENT TO CORRECT B3 DATE OF EVENT FROM 12-FEB-2024 TO 12-MAR-2024, AND TO CORRECT THE ORIGINAL G3 DATE RECEIVED BY MANUFACTURER FROM 12-FEB-2024 TO 12-MAR-2024.
DURING AN ENDOSCOPIC PROCEDURE TO PROVIDE HEMOSTASIS, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS INITIALLY REPORTED THAT IT DID NOT WORK [UNABLE TO SPRAY]. THE DEVICE WAS HELD UPRIGHT. THEY IMMEDIATELY OPENED A NEW PRODUCT AND THEY PREPARED IT THE SAME STEPS AS THE PRODUCT INVOLVED IN THE COMPLAINT, FOLLOWING THE STEPS OF INSTRUCTIONS OF USE AND EVERYTHING WORKED PERFECT WITH THE SECOND UNIT. OUR ATTEMPT TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2048274 | HEMOSPRAY ENDOSCOPIC HEMOSTAT | HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE | QAU | WILSON-COOK MEDICAL INC | W4555704 | 00827002246638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | ENDOSCOPE, UNKNOWN MAKE OR MODEL |