BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENEW RIGID SHAFT HANDPIECE, 42 CM, REUSABLE

    MDR report key: 12578150 · Received October 5, 2021

    Report

    Report Number
    1223422-2021-00009
    Event Type
    Injury
    Date Received
    October 5, 2021
    Date of Event
    May 7, 2021
    Report Date
    October 5, 2021
    Manufacturer
    MICROLINE SURGICAL INC.
    Product Code
    GEI
    UDI-DI
    00811099010616
    PMA / PMN Number
    K962119
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A RENEW HANDPIECE AND THE 3142 TIP THAT WAS USED DURING THE SURGERY WHEN THIS ADVERSE EVENT OCCURED WERE BOTH RETURNED TO MSI FOR INVESTIGATION. THE ITEMS WER RETURNED, DECONTAMINATED, VISUALLY INSPECTED AND LAB EVALUATED. AFTER EVALUATION THE COMPLAINT IS CONFIRMED. THE HANDPIECE WAS RETURNED WITH NO REMNANT OF AN O-RING LEFT ON THE DEVICE -INDICATING THAT THEY HAD PROBABLY BEEN USING THIS DEVICE WITHOUT A PROPER O-RING FOR SOME TIME. THE PEEK OUTER TUBE AT THIS DISTAL END HAS BURN/MELT MARKS WHERE THE ELECTRICAL ARCING OCCURRED DURING THE PROCEDURE, SEE IMAGE ATTACHED. THIS IS CLEARLY A VERY OLD HANDPIECE WITH THE MICROLINE PENTAX NAME STILL ON THE TOP COVER, THERE ARE INDICATIONS OF GENERAL WEAR ON THE DEVICE BUT IN GENERAL IT IS IN SATISFACTORY CONDITION OTHERWISE. THERE WERE NO OTHER ALTERATIONS TO THE DEVICE NOTED - THE OUTER PEEK SHAFT, ROTATIONAL KNOB, TOP COVER, CAUTERY POST AND HANDLE COMPONENTS APPEAR ARE THE ORIGINAL PARTS WITH NO ALTERATIONS OR ALTERNATE PARTS USED. THE 3142 DISPOSABLE TIP WAS ALSO RETURNED WITH THE HANDPIECE. THERE IS NO DAMAGE TO THE BACKHUB FROM THE ELECTRICAL EVENT. THE MICROLINE HEATSHRINK IS STILL ON THE TIP, HOWEVER THERE ARE SOME SIGNS OF WEAR ON THE HEATSHRINK THAT MAY INDICATE THAT THE TIP MAY HAVE BEEN STERILIZED AND REUSED. THEY APPEAR TO BE LIGHT SCRATCHES AND MARKS ON THE HEATSHRINK, SOMETHING THAT I WOULD NOT EXPECT TO SEE ON A ONE-TIME USED DEVICE.

    Description of Event or Problem · 1

    REUSABLE LAPAROSCOPIC INSTRUMENTS AND DISPOSABLE TIP WERE INSPECTED PRIOR TO PUTTING TOGETHER FOR ANY VISUAL DEFECTS. NONE NOTED. WHILE SURGEON WAS USING A EXTRALONG MICROLINE LAPAROSCOPIC HANDLED INSTRUMENT WITH A DISPOSABLE SCISSOR TIP, SURGICAL FIRST ASSISTANT NOTICE A PLUME COMING FROM THE THREADED PORTION, THE DISTAL END OF INSTRUMENT. SURGEON WAS ASKED TO STOP AND IT WAS OBSERVED THAT THERE WAS 1/3 OF CM THERMAL DAMAGE. GENERAL SURGEON WAS CONSULTED AND OVERSEWED THE INJURY. THE INJURY DID NOT ENTER THE SEROSAL LAYER AND THE GENERAL SURGEON DID STATE THAT IT COULD HAVE BEEN LEFT ALONE BUT SINCE HE WAS THERE IT WAS OVERSEWN. THE AREA OF INJURY WAS THE DESCENDING COLON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472287 RENEW RIGID SHAFT HANDPIECE, 42 CM, REUSABLE MANUAL DETACHABLE SURGICAL INSTRUMENTS GEI MICROLINE SURGICAL INC. 3925 00811099010616

    Patients

    Seq Age Sex Outcome Treatment
    1 Other