BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C4120, 38CM LATIS GRASPER CART, 10/BX

    MDR report key: 10830324 · Received November 12, 2020

    Report

    Report Number
    2027111-2020-00616
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    November 5, 2020
    Report Date
    January 28, 2021
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    NWV
    UDI-DI
    00607915116866
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. ENGINEERING DISASSEMBLED THE EVENT UNIT AND OBSERVED THAT ONE OF THE JAWS HAD DISLODGED FROM ITS TRACK. DAMAGE WAS ALSO OBSERVED ON THE POST OF THE JAW. BASED ON THE CONDITION OF THE RETURNED UNIT AND THE DESCRIPTION OF THE EVENT, THE JAWS WERE UNABLE TO OPEN DUE TO THE DISLODGEMENT OF ONE OF THE JAWS. IT IS LIKELY THAT THIS WAS CAUSED BY A LARGE FORCE THAT WAS APPLIED TO THE JAWS DURING USE, WHICH DAMAGED THE POST OF THE JAW. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL. THIS EVENT WAS INITIALLY REPORTED IN ERROR AND IS NOT REPORTABLE AS THE JAWS WERE REMOVED FROM THE TISSUE WITHOUT INJURY AND IT IS UNLIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS TO FOLLOW UP MEDWATCH REPORT # 2027111-2020-00616.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: TLH GRASPER WOULD NOT RELEASE TISSUE AFTER HOLDING TISSUE BETWEEN JAWS THE CLINICIANS TRIED TO OPEN THE GRASPER BY REMOVING THE HANDLE AND THE JAWS STILL DIDN'T OPEN. THIS WAS ATTEMPTED 3 TIMES WITH AND WITHOUT THE HANDLE AND EVENTUALLY THE TISSUE WAS RELEASED WITH NO INJURY TO PATIENT. PATIENT STATUS: PATIENT IS FINE, AND COMPLETELY UNAFFECTED.

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: TLH. CER2020-002610 1 OF 2; CER2020-002611 2 OF 2. GRASPER WOULD NOT RELEASE TISSUE AFTER HOLDING TISSUE BETWEEN JAWS. THE CLINICIANS TRIED TO OPEN THE GRASPER BY REMOVING THE HANDLE, AND THE JAWS STILL DIDN'T OPEN. THIS WAS ATTEMPTED 3 TIMES WITH, AND WITHOUT THE HANDLE, AND EVENTUALLY THE TISSUE WAS RELEASED WITH NO INJURY TO PATIENT. INTERVENTION: NI. PATIENT STATUS: PATIENT IS FINE, AND COMPLETELY UNAFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294428 C4120, 38CM LATIS GRASPER CART, 10/BX LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC NWV APPLIED MEDICAL RESOURCES C4120 1386285 00607915116866

    Patients

    Seq Age Sex Outcome Treatment
    1