BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 5587211 · Received April 19, 2016

    Report

    Report Number
    0001056128-2016-00043
    Event Type
    Malfunction
    Date Received
    April 19, 2016
    Date of Event
    March 16, 2016
    Report Date
    March 21, 2016
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NLM
    PMA / PMN Number
    K062497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. IT WAS REPORTED THE DEVICE IS BEING HELD BY RISK MANAGEMENT. NO DEVICE INFORMATION WAS REPORTED AS THE DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS. THEREFORE, THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE VERIFIED. A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THEREFORE, THE MOST LIKELY ROOT CAUSES ARE TOO MUCH FORCE OR TORQUE APPLIED TO DEVICE AND/OR DAMAGE TO THE DEVICE DURING SHIPPING, HANDLING, OR STORAGE AT THE USER FACILITY. THE INSTRUCTIONS FOR USE (IFU) STATE: "DAMAGE TO THE INSTRUMENT CAN LEAD TO PATIENT INJURIES. ALWAYS INSPECT INSTRUMENT CAREFULLY FOR OVERALL INTEGRITY BEFORE USE." "CAREFUL HANDLING OF INSTRUMENTS IS NECESSARY TO AVOID DAMAGE OR BREAKAGE." "INSPECT THE INSTRUMENTS FOR ANY DAMAGE. DO NOT USE THE INSTRUMENT IF ANY DAMAGE IS NOTED. RETURN THE INSTRUMENT AND PACKAGING TO STRYKER SUSTAINABILITY SOLUTIONS IF IT IS NOT IN ACCEPTABLE CONDITION FOR SURGERY." THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS AFTER THE INITIAL MDR WAS FILED. VISUAL INSPECTION OF THE DEVICE SHOWED THE DEVICE WAS RETURNED WITH EVIDENCE OF CLINICAL USE. VISUAL INSPECTION OF THE RETURNED COMPLAINT DEVICE REVEALED PART OF THE STABILITY PLUG HOUSING THAT HOLDS THE STABILITY PLUG SUTURE CLIP WAS BROKEN OFF. THE UPDATED INVESTIGATION RESULTS CONFIRM THIS INCIDENT NO LONGER FALLS WITHIN MDR REPORTABILITY REQUIREMENTS. THERE WAS NO PATIENT INJURY AND NO HISTORY OF INJURY FROM THIS FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TROCAR FELL APART INTO MULTIPLE PIECES DURING USE. A PLASTIC PIECE FELL INTO THE PATIENT AND WAS RETRIEVED USING A GRASPER THROUGH THE TROCAR PORT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. EXTENDED PROCEDURE TIME WAS REPORTED AS 20 TO 30 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TROCAR FELL APART INTO MULTIPLE PIECES DURING USE. A PLASTIC PIECE FELL INTO THE PATIENT AND WAS RETRIEVED USING A GRASPER THROUGH THE TROCAR PORT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. EXTENDED PROCEDURE TIME WAS REPORTED AS 20 TO 30 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242636 NA LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED NLM STRYKER SUSTAINABILITY SOLUTIONS LAKELAND H12LP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1