HEMOSPRAY ENDOSCOPIC HEMOSTAT
Report
- Report Number
- 1037905-2024-00033
- Event Type
- Malfunction
- Date Received
- January 16, 2024
- Date of Event
- December 21, 2023
- Report Date
- February 12, 2024
- Manufacturer
- WILSON-COOK MEDICAL INC
- Product Code
- QAU
- UDI-DI
- 00827002565722
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CONTINUED: SECTION G: 510K: 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. THE PHOTOS PROVIDED SHOW THE PRODUCT TRAY AND THE COMPLAINT DEVICE. THE PHOTOS OF THE COMPLAINT DEVICE SHOW THE DEVICE IN THE TRAY WITH THE CO2 [CARBON DIOXIDE] CARTRIDGE AND RED ACTIVATION KNOB. THE RED ACTIVATION KNOB IS SHOWN TO HAVE BROKEN AT THE BOTTOM. THE LOT NUMBER PROVIDED IN THE PHOTOS MATCHES THIS REPORT. THE LABEL IN THE PHOTO MATCHES THE PRODUCT REPORTED. OUR EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. BOTH CATHETERS WERE INCLUDED IN THE RETURN, NEITHER CONTAINED ANY POWDER. THE RED ACTIVATION KNOB HAS BROKEN AT THE BOTTOM AND ALL SEGMENTS HAVE RETURNED. THE CO2 CARTRIDGE WAS FULLY PUNCTURED. THE WHITE BODY OF THE DEVICE HANDLE HAS NOT CRACKED AND, EXTERNALLY, WAS NOT DAMAGED. HOWEVER, NOT ALL OF THE INTERNAL HANDLE COMPONENTS WERE INCLUDED IN THE RETURN. THE LANCE, FOAM, AND BLACK O-RING WERE NOT INCLUDED IN THE RETURN. 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. THE IQC RECORDS WERE VERIFIED FOR THE ASSOCIATED RAW MATERIAL LOT WAS 100% PROOF LOADED DURING INSPECTION. THE LOT PASSED ALL TESTING INDICATING THE COMPONENT WAS CONFORMING. INVESTIGATION CONCLUSION: OUR EVALUATION OF THE PRODUCT SAID TO BE INVOLVED AND THE PHOTOS PROVIDED CONFIRMED THE REPORT. HOWEVER, WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE CONDITION OF THE PRODUCT SAID TO BE INVOLVED PROHIBITED A COMPLETE EVALUATION. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. THE DESCRIPTION OF EVENT INDICATES THAT THE DEVICE WAS LEFT ACTIVATED FOLLOWING THE COMPLETION OF THE INITIAL DEMONSTRATION. THE IFU STATES: "UPON COMPLETION OF PROCEDURE, DEPRESSURIZE DEVICE BY ROTATING ACTIVATION KNOB COUNTERCLOCKWISE UNTIL CO2 CARTRIDGE DEPRESSURIZES COMPLETELY." THIS IS THE MOST LIKELY CAUSE OF THE EVENT. THE DEVICE SHOULD NOT BE LEFT UNDER PRESSURE. IF THE DEVICE IS LEFT WITH THE CO2 ACTIVATED FOR AN EXTENDED PERIOD OF TIME "MECHANICAL CREEP" OF THE MATERIAL IS POSSIBLE RESULTING IN A SUDDEN DISCHARGE OF CO2, DAMAGING THE DEVICE. 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 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. ADDITIONAL COMMENTS REGARDING THIS REPORT: BASED ON THE INFORMATION PROVIDED THAT THE DEVICE WAS LEFT ACTIVATED FOLLOWING THE COMPLETION OF THE INITIAL DEMONSTRATION, THE COOK REPRESENTATIVE HAS BEEN CONTACTED TO PROMOTE UNDERSTANDING RELATED TO APPROPRIATE USAGE/DEMO OF THIS PRODUCT.
CONTINUED: SECTION G: 510K: K200972. THE INVESTIGATION IS ON-GOING BECAUSE THE DEVICE WAS RECEIVED AT THE TIME OF THIS REPORT. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.
THE COOK SALES REPRESENTATIVE WAS CONDUCTING MULTIPLE TRAINING DEMONSTRATIONS OF THE HEMOSPRAY DEVICE ON THE SAME DAY. THERE WERE NO PATIENTS INVOLVED AS THIS TRAINING SPECIFICALLY UTILIZED NON-PATIENT SIMULATED MATERIAL. WHILE DEMONSTRATING THE DEACTIVATION PROCESS OF THE HEMOSPRAY, THE DEVICE [ACTIVATION KNOB] FORCEFULLY BROKE INTO TWO PIECES. A PARTICIPATING NURSE WAS HIT BY A PIECE AND A FRAGMENT HIT THE WALL. THE NURSE EXPERIENCED REDNESS ON HER STOMACH AND REQUIRED NO INTERVENTIONS NOR FIRST AID. ADDITIONAL COMMUNICATION WAS RECEIVED ON JAN 29, 2024 ABOUT A CONVERSATION BETWEEN THE COOK SALES REPRESENTATIVE AND THE HEAD NURSE, STATING THE NURSE IN QUESTION HAS RETURNED TO WORK AT BEAUMONT HOSPITAL. PER THE HEAD NURSE, "I PERSONALLY SPOKE WITH [THE NURSE IN QUESTION], AND SHE MENTIONED SEEKING MEDICAL ATTENTION DUE TO BRUISING AND FEELING SORE. HOWEVER, SHE REASSURED ME THAT SHE IS NOW FINE AND HAS NO ONGOING ISSUES."
THE COOK SALES REPRESENTATIVE WAS CONDUCTING MULTIPLE TRAINING DEMONSTRATIONS OF THE HEMOSPRAY DEVICE ON THE SAME DAY. THERE WERE NO PATIENTS INVOLVED AS THIS TRAINING SPECIFICALLY UTILIZED NON-PATIENT SIMULATED MATERIAL. WHILE DEMONSTRATING THE DEACTIVATION PROCESS OF THE HEMOSPRAY, THE DEVICE ACTIVATION KNOB FORCEFULLY BROKE INTO TWO PIECES. A PARTICIPATING NURSE WAS HIT BY A PIECE AND A FRAGMENT HIT THE WALL. THE NURSE EXPERIENCED REDNESS ON HER STOMACH AND REQUIRED NO INTERVENTIONS NOR FIRST AID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1653272 | HEMOSPRAY ENDOSCOPIC HEMOSTAT | HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE | QAU | WILSON-COOK MEDICAL INC | W4758714 | 00827002565722 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |