BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE REPOSITIONABLE CLIP

    MDR report key: 16519438 · Received March 9, 2023

    Report

    Report Number
    9614641-2023-00358
    Event Type
    Injury
    Date Received
    March 9, 2023
    Date of Event
    November 18, 2022
    Report Date
    September 5, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    PKL
    UDI-DI
    04953170385940
    PMA / PMN Number
    K123601
    Removal / Correction Number
    Z-1987-2023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE SUBJECT DEVICE WAS MANUFACTURED IN APRIL 2022, BUT THE SPECIFIC DATE IS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. OLYMPUS CONFIRMED "DEPLOY PREMATURELY" IS REPRODUCED WHEN THE CLIP ARM IS OPENED AND CLOSED USING A METHOD NOT RECOMMENDED/INCLUDED IN THE INSTRUCTIONS FOR USE (PERFORMED ON LOT 24K - 2YK AND REPRODUCED AT 24K). IN ADDITION, THE DIMENSIONS OF THE AVAILABLE LOTS (24K TO 2YK) WERE CHECKED TO SEE IF THE OCCURRENCE OF THIS PHENOMENON WAS CAUSED BY THE DIMENSIONS OF THE PARTS. THE DIMENSIONS OF THE HOOKS AND CLIP ARM RELATED TO THIS PHENOMENON WERE WITHIN THE STANDARD VALUES. HOWEVER, IN 24K, THE CLEARANCE BETWEEN THE HOOK AND CLAW VARIED TOWARD A SMALLER VALUE COMPARED TO OTHER LOTS. "DEPLOY PREMATURELY" IS MORE LIKELY TO OCCUR WHEN CLEARANCES ARE SMALLER. THE CLEARANCE PLAYS A SIGNIFICANT ROLE TO OPEN AND CLOSE THE CLIP ARM. SIZE OF THE CLEARANCE AFFECTS DETACHMENT OF THE CLIP ARM AND OPERABILITY SUCH AS ¿ DEPLOY PREMATURELY¿. DETACHMENT OF THE CLIP ARM EASILY OCCURS WHEN THE CLEARANCE BECOMES LARGER. ON THE OTHER HAND, ¿DEPLOY PREMATURELY¿ EASILY OCCURS WHEN THE CLEARANCE BECOMES SMALLER. THE CLEARANCE OF THE MEASURED PRODUCTS FELL WITHIN THE STANDARD VALUES. HOWEVER, IT WAS CONFIRMED THAT THE SIZE OF CLEARANCE WAS CLOSE TO THE LOWER LIMIT. WHEN THE CLEARANCE IS SMALL, THE CLIP ARM WILL BE PLACED IN A SPECIFIC POSITION AGAINST THE HOOK. WHEN THE INCORRECT STEPS ARE FOLLOWED, SUCH AS CLOSING THE CLIP ARM IN THE TUBE SHEATH, OR OPENING AND CLOSING THE CLIP ARM REPEATEDLY BY NOT GRASPING ANYTHING IN THE CLIP ARM, CAUSING THE CLIP PIPE TO GET STUCK AT THE REAR END. THIS POSSIBLY LEADS TO "DEPLOY PREMATURELY". BASED ON THE RESULTS OF THE INVESTIGATION, AN ASSOCIATION BETWEEN ADVERSE EVENTS AND THE DEVICE COULD NOT BE RULED OUT. IT IS LIKELY THE EVENT OCCURRED WHEN THE CLIP COULD NOT BE REOPENED BECAUSE THE "DEPLOY PREMATURELY" OCCURRED. IT IS ALSO POSSIBLE THAT THE LIMITER WAS RUPTURED AND COULD NO LONGER BE RELEASED. BASED ON THE RESULTS OF THE PRESENT PRODUCT CONFIRMATION AND THE RESULTS OF THE REPRODUCTION STUDY TO DATE, IT IS CONSIDERED THAT THE TRIGGER EFFECT WAS NOT OBTAINED DUE TO THE FOLLOWING MECHANISM: 1. THE SLIDER WAS PULLED FOR THE CLIPPING. 2. DUE TO THE FOLLOWING COMPOUNDED FACTORS, A FORCE OF PULLING THE SLIDER WAS REDUCED BEFORE IT REACHED TO THE CLIP. - RESISTANCE BETWEEN THE OPERATION WIRE AND THE COIL SHEATH INCREASED DUE TO THE SHAPE OF THE SCOPE OR EXCESSIVE ANGLE OF THE SCOPE. - THE AMOUNT OF FORCE REQUIRED TO CLOSE THE CLIP INCREASED DUE TO THE LARGE AMOUNT OF GRASPING OBJECT. - HARD TISSUES WERE GRASPED. - THE BASE OF THE ARM WAS PRESSED AGAINST THE TISSUE, MAKING IT DIFFICULT TO CLOSE THE CLIP. 3. A FORCE REQUIRED TO CLOSE THE CLIP DID NOT BE REACH TO THE CLIP. THEREFORE, THE LIMITER LOCATED IN THE SLIDER BROKE (HEARD THE SNAPPING SOUND) BEFORE THE CLIP COMPLETELY CLOSES. 4. SINCE THE LIMITER MADE A SNAPPING NOISE, THE USER PULLED THE SLIDER AS HE/SHE WAS MISUNDERSTANDING THAT THE CLIPPING WAS COMPLETED. 5. SINCE THE CLIP WAS NOT CLOSED COMPLETELY, IT COULD NOT BE RELEASED. (THE CLIP ARMS WERE BEING OPENED.) AS FOR "DEPLOY PREMATURELY" THERE WERE NO PROBLEMS IN THE INVESTIGATION, AND NO ABNORMALITIES WERE FOUND IN THE PRODUCT. THE EVENT CAN BE DETECTED AND PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: -"WHEN THE BENDING SECTION OF THE ENDOSCOPE IS EXCESSIVE ANGULATION AND/OR THE TARGET TISSUE IS FIRM, THE PULLING FORCE ACTED ON THE CONTROL SECTION MAY NOT CONVEY TO THE CLIP ADEQUATELY, MAKING CLIPPING UNSUCCESSFUL. -OPERATION OF THIS INSTRUMENT IS BASED ON THE ASSUMPTION THAT OPEN SURGERY IS POSSIBLE AS AN EMERGENCY MEASURE IF THE CLIP CANNOT BE DETACHED FROM THE INSTRUMENT OR IF ANY OTHER UNEXPECTED CIRCUMSTANCE TAKES PLACE. IN THIS CASE, REFER TO CHAPTER 14, ¿EMERGENCY TREATMENT¿. -DO NOT WITHDRAW THE INSTRUMENT FORCIBLY OR CHANGE THE ANGULATION OF THE ENDOSCOPE WHEN THE CLIP IS GRASPING THE TISSUE AND IS NOT RELEASED. DOING SO MAY TEAR TISSUE INSIDE THE BODY CAVITY, RESULTING IN PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. -DO NOT ANGULATE THE BENDING SECTION OF THE ENDOSCOPE OR WITHDRAW THE INSTRUMENT FROM THE ENDOSCOPE WHILE THE CLIP IS GRASPING THE TISSUE BEFORE BEING RELEASED. THIS COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. -DO NOT TRY TO FORCIBLY WITHDRAW THE INSTRUMENT FROM THE ENDOSCOPE IF THE CLIP CANNOT BE DETACHED FROM THE INSTRUMENT. FORCIBLY WITHDRAWING THE INSTRUMENT COULD CAUSE PATIENT INJURY SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. -SHOULD THE SLIGHTEST IRREGULARITY AND/OR BREAKAGE OF THE PARTS BE SUSPECTED, WITHDRAW THE INSTRUMENT FROM THE ENDOSCOPE IMMEDIATELY ACCORDING TO THE STEPS OF ¿WITHDRAWING THE INSTRUMENT FROM THE ENDOSCOPE¿ ON PAGE 10. OTHERWISE, PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE MAY RESULT. -DO NOT FORCE THE CLIP AGAINST BODY CAVITY TISSUE. THIS COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. THE CLIP MAY BE DEFORMED AND THEREFORE DOES NOT CLOSE PROPERLY. THIS COULD RESULT IN REDUCED PERFORMANCE. -KEEP THE INSERTION PORTION OF THE INSTRUMENT THAT EXTENDS FROM THE BIOPSY VALVE AND THE INSERTION PORTION OF THE ENDOSCOPE AS STRAIGHT AS POSSIBLE. " OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS ALSO BEEN SUBMITTED ON MEDWATCH REPORT #2429304 - 2023 - 00040-1.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. THIS REPORT HAS ALSO BEEN SUBMITTED ON MEDWATCH REPORT #2429304-2023-00040.

    Description of Event or Problem · 0

    OLYMPUS FURTHER RECEIVED INFORMATION THAT THE USER HAD TO RIP THE CLIP OFF OF THE TISSUE BECAUSE IT WAS NOT DISCONNECTING FROM THE CATHETER. THE CLIPS DID NOT REMAIN IN THE PATIENT. NO ADDITIONAL INTERVENTIONS DONE. THE PATIENT WAS NOT HOSPITALIZED OR HAD THEIR PERIOD OF HOSPITALIZATION EXTENDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A POLYPECTOMY SURGICAL PROCEDURE, THE SINGLE USE REPOSITIONABLE CLIPS DID NOT REOPEN AFTER GRABBING THE TISSUE WHICH CAUSED MORE BLEEDING. THERE WAS A REPORT OF A AN APPROXIMATELY 15 MINUTES. THERE WAS NO BLOOD TRANSFUSION OR FLUIDS GIVEN DUE TO THE BLEEDING. THE CASE WAS COMPLETED WITH COMPETITOR CLIPS. THIS COMPLAINT REQUIRES 3 REPORTS: THE RELATED REPORTS ARE AS FOLLOWS: (B)(6) -DEVICE # 1 OF 3. (B)(6) -DEVICE# 2 OF 3. (B)(6) -DEVICE # 3 OF 3. THIS MEDWATCH REPORTS IS FOR (B)(6) -DEVICE# 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922461 SINGLE USE REPOSITIONABLE CLIP SINGLE USE REPOSITIONAL CLIP PKL AOMORI OLYMPUS CO., LTD. HX-202UR 24K 04953170385940

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention