HEMOSPRAY ENDOSCOPIC HEMOSTAT
Report
- Report Number
- 1037905-2018-00539
- Event Type
- Malfunction
- Date Received
- November 20, 2018
- Date of Event
- October 29, 2018
- Report Date
- October 29, 2018
- Manufacturer
- COOK ENDOSCOPY
- Product Code
- QAU
- UDI-DI
- 00827002246638
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
INFORMATION REGARDING COMMON DEVICE NAME SUSPECT MEDICAL DEVICE COMMON DEVICE NAME: NOT AVAILABLE REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE. INFORMATION REGARDING PMA/510K: DEN170015. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. HOWEVER, ALL THE COMPONENTS WERE NOT INCLUDED IN THE RETURN (NO RETURNED CATHETERS) THEREFORE, A COMPLETE EVALUATION WAS NOT POSSIBLE. THE DEVICE WAS RETURNED WITH THE ON/OFF SWITCH IN THE "OFF" POSITION WITH THE RED ACTIVATION KNOB ENGAGED IN THE HANDLE FOR ACTIVATION OF THE CARBON DIOXIDE CARTRIDGE. THE POWDER CHAMBER WAS APPROXIMATELY HALF WAY EMPTY OF POWDER. WHEN TESTED AS RETURNED, THE DEVICE DID NOT SPRAY. THE RED ACTIVATION HANDLE WAS REMOVED, NO CARBON DIOXIDE HAD REMAINED IN THE CARTRIDGE. THE LANCE POSITION WAS MEASURED USING A TOOL AND FOUND TO BE POSITIONED CORRECTLY. 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. WHEN RETESTED WITH A NEW CARBON DIOXIDE CARTRIDGE, THE DEVICE SPRAYED POWDER. INITIALLY, THE DEVICE SPRAYED POWDER WITH SLIGHT VARIABILITY IN STRENGTH. HOWEVER, AFTER THE FIRST COUPLE SPRAYS, THE DEVICE SPRAYED POWDER AS INTENDED AND THE FLOW WAS A CONTINUOUS STRENGTH WHEN THE BUTTON WAS PRESSED. 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: A DEFINITIVE CAUSE FOR THIS OBSERVATION 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. FURTHERMORE, WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE CATHETERS WERE NOT RETURNED FOR EVALUATION. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. CATHETER OCCLUSION CAN BE A CAUSE OF THIS DEVICE NOT BEING ABLE TO SPRAY POWDER. CATHETER OCCLUSION CAN BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE. TO ASSIST THE USER, THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "NOTE: DO NOT TEST DEVICE PRIOR TO INSERTION INTO ENDOSCOPE ACCESSORY CHANNEL AS THIS MAY INCREASE RISK OF CATHETER OCCLUSION. 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. NOTE: IF CATHETER BECOMES OCCLUDED, TURN RED VALVE TO CLOSED POSITION, REMOVE CATHETER FROM ENDOSCOPE AND REPLACE WITH EXTRA CATHETER PROVIDED IN PACKAGE." PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS 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: 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 HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE CATHETER WAS INSERTED INTO THE WORKING CHANNEL OF THE ENDOSCOPE AND THE SPRAY [HANDLE] WAS CONNECTED. THE HEMOSPRAY DID NOT DEPLOY. THE CARBON DIOXIDE CARTRIDGE COULD NOT CREATE ENOUGH PRESSURE TO DISPENSE THE POWDER. THE POWDER CAME OUT WEAK. THEY USED A NEW HEMOSPRAY WITH THE SAME CATHETER AND COMPLETED THE PROCEDURE. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
DUE TO TECHNICAL DIFFICULTIES REGARDING SUBMISSION, THIS REPORT IS BEING SENT A FOLLOW UP 2. THIS IS FOLLOW UP 1. A CESUB HELP DESK REQUEST WAS SUBMITTED WITH NO RESPONSE. SUSPECT MEDICAL DEVICE: COMMON DEVICE NAME: NOT AVAILABLE. REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE. PMA/510K: DEN170015. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. HOWEVER, ALL THE COMPONENTS WERE NOT INCLUDED IN THE RETURN (NO RETURNED CATHETERS) THEREFORE, A COMPLETE EVALUATION WAS NOT POSSIBLE. THE DEVICE WAS RETURNED WITH THE ON/OFF SWITCH IN THE "OFF" POSITION WITH THE RED ACTIVATION KNOB ENGAGED IN THE HANDLE FOR ACTIVATION OF THE CARBON DIOXIDE CARTRIDGE. THE POWDER CHAMBER WAS APPROXIMATELY HALF WAY EMPTY OF POWDER. WHEN TESTED AS RETURNED, THE DEVICE DID NOT SPRAY. THE RED ACTIVATION HANDLE WAS REMOVED, NO CARBON DIOXIDE HAD REMAINED IN THE CARTRIDGE. THE LANCE POSITION WAS MEASURED USING A TOOL AND FOUND TO BE POSITIONED CORRECTLY. 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. WHEN RETESTED WITH A NEW CARBON DIOXIDE CARTRIDGE, THE DEVICE SPRAYED POWDER. INITIALLY, THE DEVICE SPRAYED POWDER WITH SLIGHT VARIABILITY IN STRENGTH. HOWEVER, AFTER THE FIRST COUPLE SPRAYS, THE DEVICE SPRAYED POWDER AS INTENDED AND THE FLOW WAS A CONTINUOUS STRENGTH WHEN THE BUTTON WAS PRESSED. 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: A DEFINITIVE CAUSE FOR THIS OBSERVATION 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. FURTHERMORE, WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE CATHETERS WERE NOT RETURNED FOR EVALUATION. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. CATHETER OCCLUSION CAN BE A CAUSE OF THIS DEVICE NOT BEING ABLE TO SPRAY POWDER. CATHETER OCCLUSION CAN BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE. TO ASSIST THE USER, THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "NOTE: DO NOT TEST DEVICE PRIOR TO INSERTION INTO ENDOSCOPE ACCESSORY CHANNEL AS THIS MAY INCREASE RISK OF CATHETER OCCLUSION... 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... NOTE: IF CATHETER BECOMES OCCLUDED, TURN RED VALVE TO CLOSED POSITION, REMOVE CATHETER FROM ENDOSCOPE AND REPLACE WITH EXTRA CATHETER PROVIDED IN PACKAGE." PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS 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: 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.
INFORMATION REGARDING COMMON NAME & PRODUCT CODE - SUSPECT MEDICAL DEVICE. COMMON DEVICE NAME: NOT AVAILABLE. REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE. (B)(4). 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. 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. CATHETER OCCLUSION CAN BE A CAUSE OF THIS DEVICE NOT BEING ABLE TO SPRAY POWDER. CATHETER OCCLUSION CAN BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE. TO ASSIST THE USER, THE INSTRUCTIONS FOR USE STATE THE FOLLOWING, "NOTE: DO NOT TEST DEVICE PRIOR TO INSERTION INTO ENDOSCOPE ACCESSORY CHANNEL AS THIS MAY INCREASE RISK OF CATHETER OCCLUSION... 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.. NOTE: IF CATHETER BECOMES OCCLUDED, TURN RED VALVE TO CLOSED POSITION, REMOVE CATHETER FROM ENDOSCOPE AND REPLACE WITH EXTRA CATHETER PROVIDED IN PACKAGE." PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS 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: 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 HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE CATHETER WAS INSERTED INTO THE WORKING CHANNEL OF THE ENDOSCOPE AND THE SPRAY [HANDLE] WAS CONNECTED. THE HEMOSPRAY DID NOT DEPLOY. THE CARBON DIOXIDE CARTRIDGE COULD NOT CREATE ENOUGH PRESSURE TO DISPENSE THE POWDER. THE POWDER CAME OUT WEAK. THEY USED A NEW HEMOSPRAY WITH THE SAME CATHETER AND COMPLETED THE PROCEDURE. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
DURING AN ENDOSCOPIC HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE CATHETER WAS INSERTED INTO THE WORKING CHANNEL OF THE ENDOSCOPE AND THE SPRAY [HANDLE] WAS CONNECTED. THE HEMOSPRAY DID NOT DEPLOY. THE CARBON DIOXIDE CARTRIDGE COULD NOT CREATE ENOUGH PRESSURE TO DISPENSE THE POWDER. THE POWDER CAME OUT WEAK. THEY USED A NEW HEMOSPRAY WITH THE SAME CATHETER AND COMPLETED THE PROCEDURE. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 929674 | HEMOSPRAY ENDOSCOPIC HEMOSTAT | QAU | COOK ENDOSCOPY | W4117834 | 00827002246638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | OLYMPUS 190 ENDOSCOPE, UNKNOWN MODEL |