BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTH 32 LHOOK LAP ELEC PKG

    MDR report key: 12802873 · Received November 12, 2021

    Report

    Report Number
    1320894-2021-00410
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Date of Event
    November 1, 2021
    Report Date
    January 14, 2022
    Manufacturer
    CONMED UTICA
    Product Code
    GEI
    PMA / PMN Number
    K952204
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: G4: THE 510K NUMBER WAS UPDATED FROM K942982 TO K952204 DUE TO TYPOGRAPHICAL ERROR. MANUFACTURER NARRATIVE: RECEIVED ONE 60-5274-132 IN OPENED ORIGINAL PACKAGING. LOT NUMBER WAS VERIFIED. PERFORMED A VISUAL INSPECTION, THE ELECTRODE TIP WAS DISASSEMBLED FROM THE DEVICE. THERE WAS NO EVIDENCE OF SOLDERING ON THE ELECTRODE. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THERE ARE FOUR COMPLAINTS FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED TO EXAMINE THE DEVICE PRIOR TO USE FOR DAMAGE. DO NOT USE IF DAMAGE IS FOUND. A DETERMINATION FOR FURTHER INVESTIGATION HAS BEEN INITIATED. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE, 60-5274-132, STEALTH 32 LHOOK LAP ELEC PKG, WAS USED DURING AN UNKNOWN PROCEDURE ON 1NOV21 WHEN IT WAS REPORTED ¿DURING USE (ABOUT ONE HOUR AFTER THE START OF SURGERY), THE TIP OF THE L-HOOK BROKE OFF AND FELL OUT INTO THE SURGICAL FIELD.¿. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE, UNKNOWN DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. ON 9NOV21, FURTHER ASSESSMENT INFORMATION RECEIVED STATES THAT THE PROCEDURE WAS A LAPAROSCOPIC CHOLECYSTECTOMY AND THAT ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE, 60-5274-132, STEALTH 32 LHOOK LAP ELEC PKG, WAS USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021. WHEN IT WAS REPORTED ¿DURING USE (ABOUT ONE HOUR AFTER THE START OF SURGERY), THE TIP OF THE L-HOOK BROKE OFF AND FELL OUT INTO THE SURGICAL FIELD.¿. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE, UNKNOWN DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. ON (B)(6) 2021, FURTHER ASSESSMENT INFORMATION RECEIVED STATES THAT THE PROCEDURE WAS A LAPAROSCOPIC CHOLECYSTECTOMY AND THAT ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702612 STEALTH 32 LHOOK LAP ELEC PKG ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED UTICA 202101181

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown