BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETACH A TIP FENESTRATED GRASPER

    MDR report key: 3102738 · Received May 9, 2013

    Report

    Report Number
    1320894-2013-00048
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 16, 2013
    Report Date
    June 19, 2013
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K924283
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DETACHATIP MULTI-USE INSTRUMENTS ARE PROVIDED IN A VARIETY OF SHAFT CONFIGURATIONS: SCISSORS, GRASPERS, DISSECTORS, AND VARIOUS HANDLE CONFIGURATIONS. THE SUSPECT DEVICE IS A MULTI-USE LAPAROSCOPIC FENESTRATED DUCKBILL GRASPER INTENDED TO GRASP TISSUE IN A VARIETY OF ENDOSCOPIC PROCEDURES. THE DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, REVIEW WAS NOT ACCOMPLISHED AS THE DEVICE LOT NUMBER WAS NOT MADE AVAILABLE. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO CONMED CORPORATION FOR EVALUATION. THE SPECIFIC FAILURE MODE AND ASSOCIATED ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED WITHOUT EXAMINATION OF THE ACTUAL DEVICE; THEREFORE, THIS COMPLAINT IS CONSIDERED INCONCLUSIVE. THE COMPLAINT STATED, "SURGEON WAS MOVING BOWEL WITH THE CONMED INSTRUMENT #2-1008 AND NOTICED BLEEDING COMING FROM THE BOWEL. SHE DETERMINED THAN THE BLEEDING WAS CAUSED FROM THE BOWEL BEING PUNCTURED BY MECHANISM IN THE BACK OF THE JAWS THAT OPENS AND CLOSES THE INSTRUMENT." IT IS UNDERSTOOD FROM THE COMPLAINT THAT THE 2-1008 DETACHATIP II FENESTRATED DUCKBILL GRASPER JAWS PINCHED THE BOWEL DURING MANIPULATION OF THE BOWEL. IT IS BELIEVED THAT THIS OCCURRED AT THE BASE OF JAWS WHERE THE JAW SURFACES COME IN CONTACT WITH EACH OTHER. A 24-MONTH REVIEW OF THE CUSTOMER COMPLAINT HISTORY FOR DETACHATIP DEVICES IDENTIFIED NO COMPLAINTS FOR THIS SPECIFIC FAILURE MODE. THE CAUSE OF THIS COMPLAINT WAS NOT CONCLUSIVELY DETERMINED. A POTENTIAL MANUFACTURING CAUSE IS LOOSE APPLICATION OF THE DISTAL RIVET WHICH COULD CAUSE AN EXCESSIVE GAP BETWEEN THE MATING SURFACES OF THE JAWS, RESULTING IN TISSUE BEING "PINCHED" BETWEEN THE JAWS DURING ACTUATION. OTHER POTENTIAL CAUSES ARE ROUGH OR SHARP JAW MATING SURFACES, I.E., A BURR ON THE JAW SURFACE. DURING THE JAW RIVETING OPERATION DURING MANUFACTURER OF THE DEVICE, THE MANUFACTURING PROCEDURE STATES, "PERFORM A VISUAL CHECK IF THE RIVET IS FLUSH OR BELOW THE OUTER TUBE SURFACE, NO FLASH OR BURR EXIST ON THE TUBE OR RIVET, JAWS ARE TIGHTLY RIVETED AND ARE NOT LOOSE." AFTER SET UP OF THE D-TIP RIVETING MACHINE, THE FIRST FIVE (5) PARTS ARE INSPECTED FOR THIS SAME CRITERIA. THE DFU, DIRECTIONS FOR USE, DOES NOT SPECIFICALLY MITIGATE THE ISSUE IN THIS COMPLAINT, BUT STATES, "DO NOT USE THE DETACHTIP SHAFT FOR THE PURPOSES OF SUCTION/IRRIGATION OR ANY OTHER PURPOSE FOR WHICH IS IT NOT INTENDED TO BE USED. INJURY TO PATIENT AND/OR USER MAY RESULT." THE SURGEON IN THIS REPORTED INCIDENT WAS GRASPING A BOWEL WITH A FENESTRATED DUCKBILL GRASPER. THIS GRASPER IS ONLY 3/4 INCHES IN LENGTH OF USABLE JAW AREA, NOT AN ADEQUATE LENGTH TO PROPERLY MANIPULATE BOWEL WITH. ALSO,THE FENESTRATIONS ON THE JAW ARE ROUGH AND CAN BE SHARP. THE BOWEL IS A DELICATE STRUCTURE THAT IF GRASPED WITH AN INSTRUMENT NOT DESIGNED FOR BOWEL MANIPULATION CAN, AND MOST PROBABLY WILL, BE INJURED RESULTING IN BLEEDING AREAS. THE DETACHATIP BABCOCK GRASPER HAS 1 AND 1/16 INCHES OF USABLE JAW LENGTH IN THE 5 MM SHAFT AND 1 AND 11/16 INCHES OF USABLE JAW LENGTH IN THE 10 MM SHAFT DESIGN. THIS GRASPER IS SMOOTH ON THE INTERIOR OF THE JAWS AND WAS DESIGNED FOR THE MANIPULATION OF THE BOWEL STRUCTURES. AS A PAST SURGICAL CIRCULATING REGISTERED NURSE, I FEEL IF THE SURGEON WAS CONCERNED REGARDING DAMAGE TO THE BOWEL WALL STRUCTURES SHE WOULD HAVE UTILIZED THE PROPER INSTRUMENT DESIGNED FOR MANIPULATION OF THE BOWEL AND OTHER DELICATE TISSUE STRUCTURES. THE CAUSE OF THIS INCIDENT IS MOST PROBABLY USE RELATED. THE COMPLAINT INVESTIGATION COULD NOT CONFIRM OR IDENTIFY THE SPECIFIC FAILURE MODE OR ASSIGNABLE CAUSE WITHOUT EXAMINATION OF THE ACTUAL COMPLAINT DEVICE. IN ADDITION, THE INVESTIGATION HAS NOT IDENTIFIED A TREND FOR THE REPORTED FAILURE MODE REPORTED IN THIS INCIDENT; THEREFORE, CORRECTIVE ACTION IS NOT RECOMMENDED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED.

    Additional Manufacturer Narrative · 1

    THE DEVICE RETURN TO CONMED CORPORATION IS ANTICIPATED; HOWEVER, THE DEVICE HAS NOT BEEN RECEIVED TO DATE. UPON COMPLETION OF A QUALITY ENGINEERING EVALUATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "SURGEON WAS MOVING BOWEL WITH THE CONMED INSTRUMENT #2-1008 AND NOTICED BLEEDING COMING FROM THE BOWEL. SHE DETERMINED THAT THE BLEEDING WAS CAUSED FROM THE BOWEL BEING PUNCTURED BY MECHANISM IN THE BACK OF THE JAWS THAT OPENS AND CLOSES THE INSTRUMENT." IT WAS ALSO REPORTED THAT THEY, "CONVERTED TO AN OPEN PROCEDURE AND THE BOWEL INJURIES WERE REPAIRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203005 DETACH A TIP FENESTRATED GRASPER DTIP FENESTRATED GRASPER GEI CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention