BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 10837390 · Received November 13, 2020

    Report

    Report Number
    3005075853-2020-05986
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    October 26, 2020
    Report Date
    October 27, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    UDI-DI
    10705036001843
    PMA / PMN Number
    K050344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PC-000795(B)(4).337 DATE SENT: 12/11/2020 D4: BATCH # U94Z0D F10 AND H6 COMPONENT CODE: OTHERS (G07). INVESTIGATION SUMMARY THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RETURNED WITH NO APPARENT DAMAGE AND ONE CLIP LOADED IN THE JAWS WAS NOTED. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY. DURING THE ANALYSIS, THE DEVICE WAS CYCLED AND IT FED AND FORMED 2 CONFORMING CLIPS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED. ALTHOUGH THERE IS NO DIRECT EVIDENCE OF USE ERROR, THE INSTRUCTIONS FOR USE DO CONTAIN THE FOLLOWING: "CAUTION: PRIOR TO LOADING A CLIP IN THE JAWS AND FIRING THE INSTRUMENT: ENSURE THAT THE JAWS ARE FULLY OPEN BY VERIFYING THAT THE LINE OF DEMARCATION BETWEEN THE JAWS AND THE INSTRUMENT SHAFT IS PAST THE DISTAL END OF THE TROCAR CANNULA. PRIOR TO POSITIONING THE JAWS AROUND THE TUBULAR STRUCTURE OR VESSEL, LOAD A CLIP INTO THE JAWS BY PARTIALLY SQUEEZING THE TRIGGER IN A SMOOTH CONTINUOUS MOTION FOR APPROXIMATELY ONE-THIRD OF THE TOTAL FIRING STROKE. POSITION THE JAWS WITH THE PRELOADED CLIP COMPLETELY AROUND THE TUBULAR STRUCTURE OR VESSEL TO BE LIGATED. THE STRUCTURE TO BE LIGATED SHOULD BE POSITIONED AGAINST THE APEX OF THE CLIP. COMPLETE THE FIRING CYCLE BY SQUEEZING THE TRIGGER UNTIL IT STOPS AGAINST THE HANDLE TO COMPLETELY FORM THE CLIP ON THE TARGETED STRUCTURE OR VESSEL. AFTER FIRING, FULLY RELEASE THE TRIGGER. AS ADDITIONAL INSTRUCTION FOR USE, DO NOT EXCESSIVELY TWIST OR TORQUE THE INSTRUMENT JAWS WHEN POSITIONING OR FIRING THE INSTRUMENT ON A TUBULAR STRUCTURE OR VESSEL. EXCESSIVE TWISTING OR TORQUEING MAY RESULT IN CLIP MALFORMATION." IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH #: UNKNOWN. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER AND NO NON-CONFORMANCES WERE IDENTIFIED. ATTEMPTS ARE BEING MADE TO RETRIEVE THE DEVICE. TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, JAMMING OCCURRED, AND THE CLIP WAS NOT FORMED ON THE ¿CYSTIC ARTERY. THE CLIP WAS UNFORMED. THE JAWS WERE BROKEN. NO PIECES FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302450 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. EL5ML U94Z0D 10705036001843

    Patients

    Seq Age Sex Outcome Treatment
    1