BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCHSNER FCPS 8 STR SATIN

    MDR report key: 17804217 · Received September 22, 2023

    Report

    Report Number
    3014334038-2023-00157
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    August 30, 2023
    Report Date
    October 19, 2023
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    HRQ
    UDI-DI
    10381780023845
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE OCHSNER FCPS 8 STR SATIN (106220) WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION WAS PROVIDED; DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ABNORMALITIES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, A PROBABLE ROOT CAUSE OF THE DEVICE NOT STAYING LOCKED MAY BE THE RESULT OF MISALIGNED RATCHETS DUE TO WEAR OR ENVIRONMENTAL DAMAGE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RATCHET SYSTEM/OCHSNER FORCEPS 8 STR SATIN (106220) DOES NOT STAY LOCKED; IT POPS OPEN BY THE SLIGHTEST TOUCH OR MOVEMENT. DURING OBSTETRICIAN GYNECOLOGICAL CHILDBIRTH, THE INSTRUMENT WAS USED TO CLAMP THE CORD ON THE BABY. IT UNCLAMPED WITH HARDLY TOUCHING THE INSTRUMENT OR SETTING IT DOWN. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY. NO SURGICAL DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673827 OCHSNER FCPS 8 STR SATIN N/A HRQ INTEGRA LIFESCIENCES MANSFIELD AF2111 10381780023845

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown