BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX® ELC 530 LAPAROSCOPIC CLIP APPLIER

    MDR report key: 3962070 · Received July 28, 2014

    Report

    Report Number
    1320894-2014-00081
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 30, 2014
    Manufacturer
    CONMED CORPORATION
    Product Code
    HBT
    PMA / PMN Number
    K924929
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED REFLEX ELC 530 LAPAROSCOPIC CLIP APPLIER WAS EXPECTED TO BE RETURNED FOR EVALUATION; HOWEVER, DESPITE MULTIPLE ATTEMPTS TO RETRIEVE THE DEVICE, TO DATE THE DEVICE HAS NOT YET BEEN RETURNED TO CONMED (B)(4) FROM THE END-USER FACILITY. WITHOUT THE ACTUAL PRODUCT, AN EVALUATION COULD NOT BE PERFORMED AND THE ROOT CAUSE OF THE REPORTED PROBLEM WAS UNABLE TO BE DETERMINED. THE ALLEGED PROBLEM OF "CLIPS NOT CLOSING PROPERLY" THEREFORE COULD NOT BE VERIFIED. THE DEVICE WAS MANUFACTURED ON 08-JUL-2013. OF THE LOT CONTAINING 900 UNITS, THERE WERE NO OTHER SIMILAR COMPLAINTS RECEIVED. A REVIEW OF THE DHR FOUND THERE WERE NO ISSUES OR ABNORMALITIES NOTED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. IN THIS INSTANCE, THE EXACT CAUSE OF THIS REPORTED PROBLEM OF "CLIPS NOT CLOSING" WAS UNABLE TO BE DETERMINED. HOWEVER, EVALUATION OF SIMILAR COMPLAINTS REVEALED THAT THIS TYPE OF REPORTED FAILURE CAN OCCUR IF THE JAWS OF THE CLIP APPLIERS WERE "WIDENED" BEYOND SPECIFICATIONS DURING USE. PAST INVESTIGATIONS INTO THE ROOT CAUSE OF THIS REPORTED PROBLEM HAVE SHOWN THE JAWS CAN BECOME "WIDENED" IF A CLIP WAS INADVERTENTLY FIRED OVER A PREVIOUSLY APPLIED CLIP. IN ADDITION, THE "WIDENED JAWS" OBSERVED IN PAST INVESTIGATIONS WERE MOST LIKELY DUE TO MISUSE OF THE DEVICES FOR TISSUE MANIPULATION DURING THE SURGICAL PROCEDURE. TO DATE, THERE HAVE BEEN NO PATIENT LONG TERM ADVERSE EFFECTS REPORTED. THE REFLEX ELC 530 LAPAROSCOPIC CLIP APPLIER IS AN ENDOSCOPIC CLIP APPLIER HAVING APPLICATION IN A VARIETY OF LAPAROSCOPIC PROCEDURES TO LIGATE VESSELS AND OTHER SMALL TISSUE STRUCTURES. TO ENSURE PROPER FUNCTION OF THE ENDOSCOPIC CLIP APPLIER AND TO REDUCE THE RISK OF PATIENT INJURY, THE INSTRUCTION FOR USE (IFU) PROVIDES THE FOLLOWING PRECAUTIONS AND WARNINGS: DO NOT USE THE ENDOSCOPIC CLIP APPLIER ON VESSELS UPON WHICH METAL LIGATING CLIPS WOULD NOT NORMALLY BE USED. BEFORE ENDOSCOPIC INSTRUMENTS AND ACCESSORIES FROM DIFFERENT MANUFACTURERS ARE UTILIZED TOGETHER IN A PROCEDURE, VERIFY COMPATIBILITY PRIOR TO THE START OF THE PROCEDURE. ALWAYS CHECK TO SEE THAT A CLIP IS IN THE JAWS BEFORE SQUEEZING TRIGGER. CLOSING OF EMPTY JAWS ON TISSUE MAY CAUSE TISSUE DAMAGE. ALWAYS ENSURE TRIGGER IS SQUEEZED COMPLETELY AND ALLOWED TO OPEN TO FULL INITIAL POSITION. ENSURE THE TISSUE OR VESSEL FITS COMPLETELY WITHIN THE CONFINES OF THE CLIP OR HEMOSTASIS MAY BE COMPROMISED. WHEN FIRING THE INSTRUMENT, SQUEEZE TRIGGER FIRMLY AS FAR AS IT WILL GO. FAILURE TO COMPLETELY SQUEEZE THE TRIGGER COULD POSSIBLY COMPROMISE HEMOSTASIS. WHEN DIVIDING THE TISSUE NEXT TO THE CLIP, THE LENGTH OF REMAINING CUFF MUST BE EQUAL TO OR GREATER THAN THE DIAMETER OF THE VESSEL. DIVIDING THE TISSUE IMMEDIATELY NEXT TO THE CLIP, OR OTHERWISE LEAVING A SHORT INADEQUATE CUFF, MAY RESULT IN THE CLIP SLIPPING OFF THE TISSUE, COMPROMISING HEMOSTASIS. INSPECT THE LIGATION SITE TO ENSURE PROPER APPLICATION AND THAT HEMOSTASIS HAS BEEN ACHIEVED. CORRECTED DATA: ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REPORTED IN THIS SUBMISSION. THE LOT NUMBER OF THE SUSPECT MEDICAL DEVICE WAS REPORTED INCORRECTLY ON THE INITIAL MEDWATCH SUBMISSION DUE TO A TYPOGRAPHICAL ERROR. THE CORRECT LOT NUMBER OF THE SUSPECT MEDICAL DEVICE IS 1307081 AS REPORTED IN THIS SUBMISSION.

    Additional Manufacturer Narrative · 1

    THE DEVICE RETURN TO CONMED CORPORATION IS ANTICIPATED; HOWEVER, HAS NOT YET BEEN RECEIVED TO DATE. A CONMED QUALITY ENGINEERING EVALUATION WILL COMMENCE ON THE RECEIPT OF THE SUSPECT DEVICE. WHEN A QUALITY ENGINEERING INVESTIGATION OF THE REPORTED INCIDENT IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE OF THE REFLEX ELC 530 LAPAROSCOPIC CLIP APPLIER FOR THE CLOSURE OF AN ARTERIAL VESSEL ON (B)(6) 2014, THE CLIPS WERE NOT CLOSING PROPERLY AND IT WAS NECESSARY TO USE A SECOND CLIP APPLIER IN ORDER TO CLOSE THE VESSELS PROPERLY. PER THE END-USER THERE WAS A LOSS OF BLOOD AND A POTENTIAL RISK OF CAUSING INJURY TO THE ARTERIAL VESSEL. AS REPORTED, THE PROCEDURE WAS OTHERWISE COMPLETED AS PLANNED WITH NO FURTHER COMPLICATIONS OR OTHER ADVERSE EFFECTS REPORTED. TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT'S LATEST CONDITION OR ANY INDICATION THAT A SERIOUS INJURY HAS OCCURRED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: DESPITE NUMEROUS ATTEMPTS TO RETRIEVE PATIENT DEMOGRAPHICS - ALL REQUESTS REMAIN UNANSWERED TO DATE. IT WAS REPORTED THAT THIS REPORTED INCIDENT DID NOT RESULT IN ANY ADDITIONAL MEDICAL TREATMENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437839 REFLEX® ELC 530 LAPAROSCOPIC CLIP APPLIER ELC CLIP APPLIER HBT CONMED CORPORATION 1307081

    Patients

    Seq Age Sex Outcome Treatment
    1