BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R-PEAN FCPS 6-1/4 CVD SATIN

    MDR report key: 19905828 · Received August 5, 2024

    Report

    Report Number
    3014334038-2024-00158
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    July 10, 2024
    Report Date
    September 25, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    HRQ
    UDI-DI
    10381780371984
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROCHESTER-PEAN FORCEPS 6-1/4 CURVED SATIN (106171) WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ABNORMALITIES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED. FAILURE ANALYSIS: VISUAL/FUNCTIONAL EVALUATION WAS PERFORMED. IT WAS NOTED THAT THE R-PEAN FORCEPS WERE RECEIVED IN USED CONDITION WITH SCRATCHES AND WEAR ON THE SURFACE. THE JAWS WERE ABLE TO MEET PROPERLY. THE SECOND AND THIRD LOCKING RATCHETS MET TIGHTLY AND SECURELY. THE FIRST RATCHET HELD TIGHTLY; HOWEVER, APPEARED TO BE PARTIALLY OUT OF ALIGNMENT. ADDITIONAL REVIEW BY THE PRODUCT INSPECTION SITE COULD NOT DUPLICATE THE REPORTED ISSUE OF NOT LOCKING/MEETING PROPERLY. ROOT CAUSE ANALYSIS: THE REPORTED COMPLAINT WAS CONFIRMED. THE RETURNED R-PEAN FORCEPS WITH THE FIRST RATCHET APPEARING TO BE MISALIGNED DUE TO WEAR. THE ISSUE OF COMING APART MAY BE THE RESULT OF MISALIGNMENT DUE TO WEAR. SALES RECORDS INDICATE THIS LOT WAS LAST SOLD IN AUGUST 2022. PER THE INSTRUCTIONS FOR USE (IFU), "THE INSTRUMENT MUST BE INSPECTED TO ASSURE PROPER FUNCTIONING PRIOR TO EACH USE WITH PARTICULAR ATTENTION PAID TO THE CONDITION OF ALL MOVING PARTS, TIPS, BOX LOCKS, RATCHETS AND CUTTING EDGES." NO MANUFACTURING, WORKMANSHIP OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.

    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 R-PEAN FORCEPS 6-1/4 CVD SATIN (106171) FAILED TO EFFECTIVELY CLAMP DOWN (OR RATCHET) AND CAME OFF THE UMBILICAL CORD OF A NEWBORN BABY DURING DELIVERY. IT WAS SUBSEQUENTLY REPORTED THAT THE CLAMP CAME OFF THE UMBILICAL CORD CLOSEST TO BABY AFTER IT WAS CUT, IMMEDIATELY AFTER BIRTH, DURING A CAESAREAN SECTION. THERE WAS SOME BLOOD LOSS NOTED WHEN THE INFANT WAS IMMEDIATELY MOVED TO THE PANDA WARMER. A PLASTIC CLAMP WAS PLACED ON THE UMBILICAL CORD OF THE NEWBORN. THE OPERATING ROOM STAFF ALL VERIFIED THE CLAMP WAS APPLIED TO THE INFANT PRIOR TO CUTTING THE CORD; BUT IT FELL OFF IMMEDIATELY PRIOR TO THE INFANT BEING MOVED TO THE PANDA WARMER FOR RESUSCITATION. THE COUNT OF THE CLAMPS ON THE FIELD OF THE CAESAREAN-SECTION WERE CORRECT AND ALL WERE ACCOUNTED FOR. STAFF INVESTIGATED BY CHECKING THE FOUR KELLY CLAMPS IN THE INSTRUMENT CASKET AND THE KELLY IN QUESTION WAS FOUND TO CLICK BUT NOT CONNECT CORRECTLY AND IT DID NOT CLOSE CORRECTLY OR TIGHTLY. THE INFANT WAS TRANSFERRED TO HERSHEY MEDICAL CENTER TO A HIGHER LEVEL OF CARE AND DISCHARGED TWO DAYS LATER TO HOME WITH PARENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2292978 R-PEAN FCPS 6-1/4 CVD SATIN N/A HRQ INTEGRA LIFESCIENCES MANSFIELD AS2203 10381780371984

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other