HEMOSPRAY ENDOSCOPIC HEMOSTAT

Report

Report Number: 1037905-2020-00534
Event Type: Malfunction
Date Received: December 7, 2020
Date of Event: November 16, 2020
Report Date: December 7, 2020
Manufacturer: COOK ENDOSCOPY
Product Code: QAU
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 0

INFORMATION REGARDING SUSPECT MEDICAL DEVICE SECTION: COMMON DEVICE NAME: NOT AVAILABLE; REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE; PRODUCT CODE: QAU. PMA/510(K) # K200972. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT. ALL COMPONENTS WERE NOT INCLUDED IN THE RETURN (NO CATHETERS WERE RETURNED), THEREFORE A COMPLETE EVALUATION WAS NOT POSSIBLE. THE DEVICE WAS RETURNED WITH THE ON/OFF SWITCH IN THE "OFF" POSITION. THE RED ACTIVATION KNOB WAS ENGAGED IN THE HANDLE INDICATING ACTIVATION OF THE CARBON DIOXIDE (CO2) CARTRIDGE. THE NOZZLE OF THE DEVICE WAS MISSHAPEN. WHEN TESTED AS RETURNED, THE DEVICE SPRAYED POWDER AS INTENDED. A SAMPLE CATHETER WAS ATTACHED AND THE DEVICE SPRAYED AS INTENDED. THE CO2 CARTRIDGE DISCHARGED WHEN DEACTIVATED AND WAS FULLY PUNCTURED. THE LANCE POSITION WAS MEASURED 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. THE INSPECTION OF THE CO2 CARTRIDGE AND REGULATOR (LANCE AND O-RING) CONFIRMS THE DEVICE WAS OF THE CURRENT DESIGN. WHEN TESTED WITH A NEW CO2 CARTRIDGE AND ACTIVATION KNOB, THE DEVICE SPRAYED AS INTENDED. THE SAMPLE CATHETER WAS ATTACHED TO THE DEVICE FOR TESTING AND SPRAYED AS INTENDED. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: THE ROOT CAUSE FOR THE REPORT OF UNABLE TO SPRAY IS UNKNOWN. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. A CORRECTIVE ACTION HAS BEEN INITIATED CONCERNING DEVICE FAILURE DUE TO BEING UNABLE TO SPRAY POWDER. PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT IS 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.

Description of Event or Problem · 0

PRIOR TO AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN SELECTED A HEMOSPRAY ENDOSCOPIC HEMOSTAT. ACCORDING TO THE INITIAL REPORTER, A PATIENT OF UNDISCLOSED AGE AND GENDER UNDERWENT AN UPPER EGD PROCEDURE IN WHICH THE HEMOSPRAY ENDOSCOPIC HEMOSTAT WAS USED. ALL OF THE STEPS WERE FOLLOWED ACCORDINGLY AND WHEN DEPLOYED, NO POWDER CAME OUT OF THE DEVICE. THE DEVICE WAS TESTED AND NO POWDER CAME OUT. THE NURSE TURNED THE ACTIVATION KNOB AND THERE WAS A HISSING SOUND FROM THE CARBON DIOXIDE (CO2) CARTRIDGE. BUT NO POWDER WAS COMING OUT. THE NURSE ALSO CHECKED THE CATHETER TO ENSURE IT WAS NOT CLOGGED. THIS OCCURRED PRIOR TO PATIENT CONTACT. A SECOND OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER COMPLICATIONS. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

Additional Manufacturer Narrative · 1

INFORMATION REGARDING SUSPECT MEDICAL DEVICE: COMMON DEVICE NAME: NOT AVAILABLE. REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE. PRODUCT CODE: QAU. PMA/510(K) # K200972. INVESTIGATION EVALUATION: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. 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 HAS BEEN INITIATED CONCERNING DEVICE FAILURE DUE TO BEING UNABLE TO SPRAY POWDER. REFERENCE CAPA (B)(4). PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: 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.

Description of Event or Problem · 1

DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED HEMOSPRAY ENDOSCOPIC HEMOSTAT. ACCORDING TO THE INITIAL REPORTER, A PATIENT OF UNDISCLOSED AGE AND GENDER UNDERWENT AN UPPER EGD PROCEDURE IN WHICH THE HEMOSPRAY ENDOSCOPIC HEMOSTAT WAS USED. ALL OF THE STEPS WERE FOLLOWED ACCORDINGLY AND WHEN DEPLOYED, NO POWDER CAME OUT OF THE DEVICE. THE DEVICE WAS TESTED AND NO POWDER CAME OUT. THE NURSE TURNED THE ACTIVATION KNOB AND THERE WAS A HISSING SOUND FROM THE CARBON DIOXIDE (CO2) CARTRIDGE BUT NO POWDER WAS COMING OUT. THE NURSE ALSO CHECKED THE CATHETER TO ENSURE IT WAS NOT CLOGGED. A SECOND OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER COMPLICATIONS. A 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
1428801	HEMOSPRAY ENDOSCOPIC HEMOSTAT		QAU	COOK ENDOSCOPY		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1				ENDOSCOPE, UNKNOWN MODEL OR MANUFACTURER