BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURG PAT XRAY 1/2X2 -200

    MDR report key: 13308158 · Received January 20, 2022

    Report

    Report Number
    3014334038-2022-00004
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Date of Event
    November 29, 2021
    Report Date
    July 6, 2022
    Manufacturer
    RAYNHAM
    Product Code
    HBA
    UDI-DI
    10381780515012
    PMA / PMN Number
    K880402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE SURGICAL PATTIE (ID 801406) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THERE IS NO INDICATION THAT THE PRODUCTION PROCESS MAY HAVE CONTRIBUTED TO THIS COMPLAINT. ALL TEST RESULTS PASSED PROCEDURAL SPECIFICATIONS. FAILURE ANALYSIS - THE PATTIE/STRIP UNIT WAS INSPECTED USING THE UNAIDED EYE. FAILURE ANALYST WAS ABLE TO CONFIRM THE PRESENCE OF A BURN MARK ON THE PATTIE. THE COMPLAINT COULD BE VERIFIED THROUGH FAILURE ANALYSIS. ROOT CAUSE - PER THE FAILURE ANALYST, ¿COTTONOID MATERIAL IS FORMED FROM RAYON. DURING PROCESSING, THIS RAYON MATERIAL IS BROKEN DOWN INTO SMALL, LOOSE FIBERS. IF THE FIBERS DO NOT BREAK DOWN PROPERLY, A SMALL CLUSTER OF FIBERS CAN RESULT. THIS CREATES A THICK SPOT IN THE PATTIE. WHEN THE STRING OR X-RAY IS ULTRASONICALLY WELDED ON THIS SPOT IT ABSORBS MORE ENERGY THAN THE REST OF THE PATTIE AND RESULTS IN A BURN. PATTIES CREATED ON THE HYBRID MACHINES ARE VISUALLY INSPECTED DURING THE OPERATOR BEFORE BEING CARDED. OPERATORS FAN THROUGH THE STACK OF 10 PATTIES COUNTING EACH PATTIE AND ENSURING THERE ARE NO DEFECTS. THEY THEN FLIP OVER THE STACK AND REPEAT BEFORE ATTACHING THE STACK TO A CARD. BECAUSE THE BURN MARK WAS MISSED THE COMPLAINT CAN BE ATTRIBUTED TO OPERATOR ERROR. OPERATORS WILL BE RETRAINED PER AN INSTRUCTOR LED TRAINING.¿ THERE IS CURRENTLY AN OPEN CORRECTIVE ACTION TO INVESTIGATE THE PATTIES/STRIPS PRODUCT FAMILY.

    Additional Manufacturer Narrative · 0

    THE SURGICAL PATTIE WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    A FACILITY REPORTED A STAIN ON SURGICAL PATTIE (801406). ISSUE DETECTED DURING INSPECTION. NO PATIENT CONTACT/INJURY REPORTED AND THE EVENT DID NOT LED TO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67809 SURG PAT XRAY 1/2X2 -200 SURGICAL PATTIES HBA RAYNHAM 801406 10381780515012

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown