BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOWELL D.A.S.H. SPHINCTEROTOME

    MDR report key: 1074494 · Received July 9, 2008

    Report

    Report Number
    1037905-2008-00089
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 13, 2008
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    PMA / PMN Number
    K901443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: WE WERE UNABLE TO CONFIRM THE REPORT AS IT WAS DESCRIBED BECAUSE THE AFFECTED SPHINCTEROTOME WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVAL. AFTER A REVIEW OF THE 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. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CONCLUSIONS: WE WERE UNABLE TO CONDUCT A FULL INVESTIGATION BECAUSE THE SPHINCTEROTOME WAS DISCARDED AND NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION WAS UNABLE TO BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PT ANATOMY, SCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE CANNOT REPRODUCE THE ACTUAL CONDITIONS OF DEVICE USAGE DURING THE PROCEDURE. WHILE THESE ARE NOT THE SOLE DETERMINING FACTORS, THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE THE CAUSE FOR THE REPORTED OBSERVATION. HOWEVER, WE CAN PROVIDE THE FOLLOWING COMMENTS: THE INSTRUCTIONS FOR USE CAUTION THE USER THAT ANY ELECTROSURGICAL ACCESSORY DEVICE CONSTITUTES A POTENTIAL ELECTRICAL HAZARD TO THE PT AND OPERATOR. THE INSTRUCTIONS FOR USE LIST POSSIBLE ADVERSE EFFECTS WHICH INCLUDE BUT ARE NOT LIMITED TO FULGURATION AN BURNS. CLINICAL PERSONNEL REVIEWED THIS INFO AND INDICATED THAT IN ORDER TO PERFORM A SPHINCTEROTOMY, A SPHINCTEROTOME CUTS AND BURNS BY USE OF THE POWER PROVIDED BY THE ELECTROSURGICAL UNIT (I.E. AN APPLICATION OF CAUTERY FROM THE ELECTROSURGICAL UNIT THROUGH THE SPHINCTEROTOME). THE CLINICAL PERSONNEL CONCLUDED THAT CUTTING AND BURNING ARE EXPECTED OUTCOMES OF SPHINCTEROTOMY. THE CONDITIONS IN WHICH THE SPHINCTEROTOME IS USED TO SAFELY CREATE THE DESIRED CUT AND BURN ARE UNDER THE DIRECT CONTROL OF THE USER. PERFORATION IS A KNOWN POTENTIAL COMPLICATION WHEN PERFORMING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). EVEN WHEN A SPHINCTEROTOME IS USED AND PERFORMS AS INTENDED, PERFORATION IS A KNOWN COMPLICATION WHEN PERFORMING AN ERCP. THE INSTRUCTIONS FOR USE FOR THE HOWELL D.A.S.H SPHINCTEROTOME LIST PERFORATION AS A POTENTIAL COMPLICATION. THE INSTRUCTIONS FOR USE DIRECT THE USER TO SWITCH THE ELECTROSURGICAL UNIT TO "OFF" POSITION WHEN NOT IN USE. IF THE ELECTROSURGICAL UNIT WAS INADVERTENTLY ACTIVATED WHILE THE CUTTING WIRE OF THE SPHINCTEROTOME REMAINED IN PLACE, THIS COULD HAVE CAUSED THE REPORTED BURNS/PERFORATIONS. THE INSTRUCTIONS FOR USE DIRECT THE USER TO ENSURE THE CUTTING WIRE OF THE SPHINCTEROTOME IS COMPLETELY OUT OF THE ENDOSCOPE TIP BECAUSE CONTACT OF THE CUTTING WIRE WITH THE ENDOSCOPE MAY CAUSE GROUNDING. THE USER IS CAUTIONED THAT THIS TYPE OF OCCURRENCE CAN RESULT IN PT INJURY. THE INFO PROVIDED INDICATED AN ELECTROSURGICAL GROUNDING PAD WAS USED DURING THIS PROCEDURE. THE INSTRUCTIONS FOR USE CAUTION THE USER TO FOLLOW THE RECOMMENDATIONS PROVIDED BY THE ELECTROSURGICAL UNIT MFR TO ENSURE PT SAFETY THROUGH PROPER PLACEMENT AND UTILIZATION OF A PT RETURN ELECTRODE. THE USER IS INSTRUCTED TO ENSURE PROPER PATH FROM THE PT RETURN ELECTRODE TO THE ELECTROSURGICAL UNIT IS MAINTAINED THROUGHOUT THE PROCEDURE. IF THE ELECTROSURGICAL GROUNDING PAD WAS NOT PROPERLY PLACED, THIS COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION. THE INFO PROVIDED INDICATED A JAGWIRE GUIDEWIRE (MFG BY BOSTON SCIENTIFIC) WAS LEFT INSIDE THE SPHINCTEROTOME DURING THE SPHINCTEROTOMY. BECAUSE WE ARE NOT THE MFR OF THE JAGWIRE GUIDEWIRE, WE ARE UNABLE TO CONFIRM IF THE JAGWIRE GUIDEWIRE CAUSED ON CONTRIBUTED TO THE REPORTED PERFORATION. PRIOR TO PACKAGING AND SHIPPING, ALL HOWELL D.A.S.H. SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTIONS: 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 THIS REPORT WAS UNABLE TO BE VERIFIED. 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 AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ECRP), THE PHYSICIAN USED A BOSTON SCIENTIFIC JAGWIRE GUIDEWIRE AND A COOK ENDOSCOPY HOWELL DAHS SPHINCTEROTOME. THE WIRE GUIDE WAS LEFT IN POSITION INSIDE THE SPHINCETROTOME AND A SPHINCETEROTOMY WAS PERFORMED. APPOXIMATELY 4 TO 6 HRS LATER, THE PT COMPLAINED OF ABDOMINAL PAIN. THE PT WAS TAKEN TO X-RAY WHICH REVEALED AIR IN THE ABDOMEN AND DUODENUM. THE MEDICAL FACILITY REPORTED THAT THE PT HAD TWO PERFORATIONS: ONE IN THE BILE DUCT AND ONE IN THE DUODENUM. THE PHYSICIAN REPORTED THAT "IT IS POSSIBLE THAT THE PERFORATIONS ARE DUE TO THE SPHINCTEROTOME SHORT CIRCUITING CAUSING THE BOSTON SCIENTIFIC JAGWIRE TO BURN A HOLE IN THE BILE DUCT AND DUODENUM". THE PT WAS SENT TO SURGERY FOR REPAIR OF THE PERFORATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOWELL D.A.S.H. SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY W2531197

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening