BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOT MAXX BIOPSY FORCEPS

    MDR report key: 1063424 · Received June 18, 2008

    Report

    Report Number
    1037905-2008-00075
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 22, 2008
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KGE
    PMA / PMN Number
    K000086
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: THE FORCEPS WERE EVALUATED BY THE FORCEPS SUPPLIER: THE EVAL OF THE RETURNED FORCEPS DEVICE WAS UNABLE TO CONFIRM THE REPORT AS DESCRIBED. A CONTINUITY TEST WAS PERFORMED AND THE FORCEPS FUNCTIONED AS INTENDED; LEAKAGE OF CURRENT WAS NOT OBSERVED. A VISUAL EVAL OF THE OUTER SHEATH CONFIRMED THE PRESENCE OF A CUT/SPLIT IN THE SHEATH APPROX HALF WAY DOWN THE LENGTH OF THE FORCEPS. A CONTINUITY READING WAS TAKEN FROM THE AREA WHERE THE COATING IS CUT/SPLIT. THIS AREA DID NOT HAVE A CONTINUITY READING, THEREFORE, THIS OBSERVATION IS NOT LIKELY RELATED TO THE REPORTED OBSERVATION. DURING A FUNCTIONAL VERIFICATION, THE CUPS OPENED AND CLOSED EACH TIME THE HANDLE WAS MANIPULATED. NO OTHER OBSERVATIONS WERE NOTED. AFTER A REVIEW OF THE COOK ENDOSCOPY DEVICE HISTORY RECORD FOR THIS LOT NUMBER, WE CAN REPORT THAT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE THE DEVICES WERE PREVIOUSLY DISTRIBUTED. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. THE REPORT OF ELECTRICAL CURRENT LEAKAGE REPRESENTS AN UNUSUAL OCCURRENCE. THE OUTCOME OF A BURN ON THE SKIN REPRESENTS AN ISOLATED OCCURRENCE. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CONCLUSION: A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION WAS UNABLE TO BE DETERMINED BECAUSE THE PRODUCT FUNCTIONED AS INTENDED. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR EVAL. HOWEVER, WE CAN PROVIDE THE FOLLOWING COMMENTS: INFO REGARDING PROPER PLACEMENT OF THE PT RETURN ELECTRODE WAS REQUESTED, BUT WAS UNABLE TO BE PROVIDED. THE REPORTED OBSERVATION CAN OCCUR IF A PROPER PATH FROM PT RETURN ELECTRODE TO THE ELECTROSURGICAL UNIT IS NOT MAINTAINED THROUGHOUT THE PROCEDURE. THE INSTRUCTIONS FOR USE INSTRUCT THE USER TO FOLLOW RECOMMENDATIONS PROVIDED BY THE ELECTROSURGICAL UNIT MFR TO ENSURE SAFETY THROUGH PROPER PLACEMENT AND UTILIZATION OF THE PT RETURN ELECTRODE. ALTHOUGH DAMAGE TO THE OUTER SHEATH IS NOT RELATED TO THE REPORTED OBSERVATION, THIS TYPE OF SHEATH DAMAGE CAN OCCUR IF THE DEVICE IS REMOVED FROM THE ENDOSCOPE AT AN ANGLE, ALLOWING THE SHEATH TO SCRAPE AGAINST THE PORT OF THE ENDOSCOPE. DAMAGE TO THE OUTER SHEATH CAN OCCUR IF THE DEVICE IS PLACED IN A TIGHT COIL. THE INSTRUCTIONS FOR USE FOR THIS PRODUCT LINE CAUTION THE USER NOT TO PLACE THE DEVICE IN A COIL SMALLER THAN 8" IN DIAMETER. PRIOR TO DISTRIBUTION, ALL HOT MAXX FORCEPS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER CONFIRMED THAT THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: THE COMPLAINT RISK PRIORITY NUMBER (CRPN) FOR THIS TYPE OF OCCURRENCE HAS BEEN CALCULATED BASED ON THE RATE OF OCCURRENCE AND SEVERITY OF THE OUTCOME. BASED ON THIS ACTIVITY, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. NO FURTHER ACTION WARRANTED AT THIS TIME BECAUSE THE REPORT WAS UNABLE TO BE CONFIRMED; THE DEVICE FUNCTIONED AS INTENDED. THIS REPORT REPRESENTS AN UNUSUAL/ISOLATED OCCURRENCE. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CUSTOMER QA WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING A HOT BIOPSY PROCEDURE THE PHYSICIAN USED COOK ENDOSCOPY HOT MAXUM BIOPSY FORCEPS. AT THE MOMENT OF TAKING THE HOT BIOPSY, THE PHYSICIAN EXPERIENCED ELECTRICAL SHOCK. A SMALL SKIN BURN ON THE PHYSICIAN'S HAND OCCURRED. THE PHYSICIAN DID NOT REQUIRE ANY ADD'L PROCEDURES, DUE TO THIS OBSERVATION. THE PHYSICIAN DID NOT EXPERIENCE ANY ADVERSE EFFECTS, DUE TO THE SMALL SKIN BURN. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADD'L MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS WERE EXPERIENCED, DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOT MAXX BIOPSY FORCEPS KGE, FORCEPS, BIOPSY, ELECTRIC KGE COOK ENDOSCOPY W2305096

    Patients

    Seq Age Sex Outcome Treatment
    1 Other