BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYN OPERATIVE 12 DEGREE 2.7MM LONG AUTOCLAVABLE

    MDR report key: 11962019 · Received June 8, 2021

    Report

    Report Number
    3011050570-2021-00076
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 17, 2021
    Report Date
    June 29, 2021
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    FHO
    UDI-DI
    00821925008915
    PMA / PMN Number
    K980972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION AND THE RESULTS OF THE DEVICE HISTORY RECORDS (DHR) REVIEW. THE DHR FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED. HOWEVER, BASED ON THE INSPECTION RESULT, PHYSICAL DAMAGE FOUND ON THE DEVICE WAS MOST LIKELY DUE TO USER MISHANDLING. THE DEVICE INSTRUCTIONS FOR USE PROVIDES WARNINGS AND CAUTIONS TO ALERT THAT THE DEVICE MAY BE DAMAGED BY IMPROPER HANDLING. IT STATES "STUDY THIS MANUAL AND OTHER LABELING THOROUGHLY FOR SAFE HANDLING AND STORAGE. MISUSE OF INSTRUMENTS CAN CAUSE INJURY TO THE PATIENT AND COULD HAVE AN ADVERSE EFFECT ON THE PROCEDURE BEING PERFORMED. DO NOT DROP INSTRUMENTS OR ALLOW THEM TO BE STRUCK BY OTHER OBJECTS."

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENT IS BEING SUBMITTED TO CORRECT THE MODEL NUMBER AND UDI NUMBER PER LEGAL MANUFACTURER REVIEW OF DEVICE HISTORY REPORT.

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION AND THE INVESTIGATION IS IN PROCESS. UPON INITIAL INSPECTION, THE OLYMPUS SERVICE CENTER CONFIRMED THE OUTER TUBE WAS BENT AND THE INTERNAL LENSES WERE CRACKED, CAUSING A LOSS OF IMAGE. DEBRIS UNDER EYEPIECE WINDOW WAS ALSO OBSERVED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO OLYMPUS, THE DEVICE SHAFT WAS BENT AND THERE WASN'T AN IMAGE. THE MALFUNCTION WAS IDENTIFIED IN REPROCESSING ON (B)(6) 2021. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859996 GYN OPERATIVE 12 DEGREE 2.7MM LONG AUTOCLAVABLE PNEUMOPERITONEUM NEEDLE FHO GYRUS ACMI, INC REXG27L-12A 00821925008915

    Patients

    Seq Age Sex Outcome Treatment
    1