BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOEHENDRA LITHOTRIPSY CABLE

    MDR report key: 1082971 · Received July 25, 2008

    Report

    Report Number
    1037905-2008-00095
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 27, 2008
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    LQC
    PMA / PMN Number
    K902170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: EVAL: WE WERE UNABLE TO CONFIRM THE REPORT AS IT WAS DESCRIBED BECAUSE THE AFFECTED PRODUCT 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. THIS REPORT REPRESENTS AN ISOLATED OCCURRENCE. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CONCLUSION: WE WERE UNABLE TO CONDUCT A FULL INVESTIGATION BECAUSE THE DEVICE WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION WAS UNABLE TO BE DETERMINED. HOWEVER, WE CAN PROVIDE THE FOLLOWING COMMENTS: THE INSTRUCTIONS FOR USE FOR THE SOEHENDRA LITHOTRIPSY CABLE CONTAIN THE FOLLOWING WARNING: DUE TO THE MECHANICAL PRESSURE GENERATED WITH THIS DEVICE, BASKET FRAGMENTATION IN COMMON THE BILE DUCT IS A POSSIBILITY THAT MAY REQUIRE SURGICAL INTERVENTION. THE INSTRUCTIONS FOR USE FOR THE SOEHENDRA LITHOTRIPSY CABLE CONTAIN THE FOLLOWING STATEMENT: ONLY SELECT COOK BILIARY SOFT WIRE BASKETS ARE RECOMMENDED FOR USE WITH THIS DEVICE. BECAUSE WE ARE NOT THE MANUFACTURER OF THE OLYMPUS EXTRACTION BASKET USED WITH THE SOEHENDRA LITHOTRIPSY CABLE, WE ARE UNABLE TO CONFIRM IF THE OLYMPUS EXTRACTION BASKET CAUSED OR CONTRIBUTED TO THE REPORTED OBSERVATION. PRIOR TO DISTRIBUTION, ALL SOEHENDRA LITHOTRIPSY CABLES ARE SUBJECTED TO A VISUAL EVAL TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MANUFACTURING 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 IS WARRANTED AT THIS TIME, BECAUSE THIS REPORT WAS UNABLE TO BE VERIFIED. THIS OBSERVATION REPRESENTS AN ISOLATED OCCURRENCE. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RATE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC PROCEDURE WITH MECHANICAL LITHOTRIPSY, THE PHYSICIAN USED A COOK ENDOSCOPY SOEHENDRA LITHOTRIPSY CABLE WITH AN OLYMPUS EXTRACTION BASKET. DURING LITHOTRIPSY, THE BASKET WAS REPORTEDLY CUT BY THE EDGE OF THE SOEHENDRA CABLE. THE BASKET BECAME ENTANGLED IN THE BILE DUCT. MECHANICAL LITHOTRIPSY WAS PERFORMED WITH A DIFFERENT SYSTEM TO CLEAR THE BILE DUCT; HOWEVER THE BASKET WAS UNABLE TO BE RETRIEVED. THE BASKET WAS RETRIEVED DURING SURGERY. THE INITIAL REPORTER INDICATED THE PT EXPERIENCED SHORT TERM ADVERSE EFFECTS DUE TO THIS OBSERVATION. THE NATURE OF THE SHORT TERM ADVERSE EFFECTS WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOEHENDRA LITHOTRIPSY CABLE LQC, LITHOTRIPTER, BILIARY MECHANICAL LQC COOK ENDOSCOPY W2496697

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R