BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPELS/SHEARS

    MDR report key: 12962544 · Received December 8, 2021

    Report

    Report Number
    2134070-2021-00030
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    October 29, 2021
    Report Date
    December 8, 2021
    Manufacturer
    STERILMED, INC.
    Product Code
    NUJ
    UDI-DI
    10888551045117
    PMA / PMN Number
    K161086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 0

    A NON-REPROCESSED ORIGINAL EQUIPMENT MANUFACTURER (OEM) DEVICE WAS RECEIVED BY STERILMED ON 16-DEC-2021 FOR ANALYSIS OF THIS COMPLAINT. FOLLOW UP WAS PERFORMED TO CONFIRM IF THIS WAS THE CORRECT DEVICE OF THIS COMPLAINT. CONFIRMATION WAS RECEIVED ON (B)(6) 2021 THAT THE DEVICE RETURNED IS THE CORRECT DEVICE FOR THE COMPLAINT AND THE INCORRECT REPROCESSED PRODUCT CODE WAS PREVIOUSLY PROVIDED. THEREFORE, STERILMED IS NOT THE MANUFACTURER OF THIS DEVICE, AND THIS COMPLAINT IS NOT FOR STERILMED. THE OEM ETHICON INC. HAS BEEN NOTIFIED OF THIS INFORMATION. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY WITH A REPROCESSED HARMONIC SCALPELS/SHEARS AND THE TIP OF DEVICE WAS BROKEN. IT IS UNKNOWN IF IT COMPLETELY DETACHED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858278 HARMONIC SCALPELS/SHEARS ELECTROSURG, CUT/COAG ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED NUJ STERILMED, INC. HAR36R 2161136 10888551045117

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown