BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDE-LOCK ROT ATRAU GRASPER DBL-ACT 5MM-NA

    MDR report key: 12219616 · Received July 23, 2021

    Report

    Report Number
    1423507-2021-00039
    Event Type
    Malfunction
    Date Received
    July 23, 2021
    Date of Event
    July 14, 2021
    Report Date
    July 19, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    HET
    UDI-DI
    10885403154461
    PMA / PMN Number
    K925079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PR # (B)(4). LOT # C21VEO - MARCH, OF 2021, B21VEO - FEBRUARY OF 2021, J19VEO - OCTOBER OF 2019 THE PRODUCT WAS RETURNED, AND AN EVALUATION WAS PERFORMED. THE ROOT CAUSE OF THIS REPORTED ISSUE WAS NOT CONFIRMED. THE INSTRUMENTS WERE MANUFACTURED ACCORDING TO THE PRODUCT SPECIFICATION DRAWING. A VISUAL AND PHYSICAL EXAMINATION WAS CONDUCTED ON EACH DEVICE. DEVICES PASSED ALL INSPECTION CRITERIA AND FUNCTION AS INTENDED. FAILURE MODE COULD NOT BE REPLICATED. A REVIEW OF DHRS 11039-01, 12338-03, AND 12419-06 REVEALED NO NON-CONFORMANCES OR DEVIATIONS. DEVICES PASS ALL INSPECTION CRITERIA AND FUNCTION AS INTENDED. FAILURE MODE COULD NOT BE REPLICATED. THIS COMPLAINT WAS ESCALATED TO A MEDICAL DEVICE REPORTABLE BY THE CUSTOMER, BD. ENDOPLUS WILL NOT FILE A REPORT BASED ON THERE BEING NO EVIDENCE OF DEVICE MALFUNCTION LEADING TO AN ADVERSE EVENT CAUSING SERIOUS INJURY 21 CFR 803.3. THERE WAS NOT ONE SPECIFIC PROCEDURE NOTED IN THE COMPLAINT NOR WERE THERE ANY MEDICAL PROCEDURES PERFORMED ON THE TISSUE. ALL PROCEDURES WERE COMPLETED AS PLANNED. BECAUSE DEVICES PASSED ALL INSPECTION CRITERIA AND FAILURE MODE COULD NOT BE REPLICATED, NO IMMEDIATE ACTION IS NECESSARY. DEVICES WILL BE RETURNED TO CUSTOMER.

    Description of Event or Problem · 1

    ATRAUMATIC SLIDE LOCK HANDLE IS VERY DIFFICULT TO UNLOCK ONCE IN THE LOCKED POSITION AND IT IS CAUSING THE JAW TO PULL AND IN SOME CASES TEAR TISSUE. THERE HAVE BEEN INSTANCES OF TORN TISSUE ON A PATIENT DUE TO THE JAW PULLING TOO HARD WHEN THE HANDLE IS UNABLE TO UNLOCK. THIS CUSTOMER RECENTLY REPLACED THEIR SLIDE LOCKS #88-8333 ACROSS THE BOARD AND THE SURGEONS STARTED NOTICING THE DIFFERENCE ALMOST IMMEDIATELY WITH THE NEW SLIDE-LOCKS. THEY HAVE HAD SURGEON COMPLAINTS FROM 3 OF THE 5 USING THIS INSTRUMENT. 19JUL2021 ADDITIONAL INFORMATION: WHAT WAS THE PROCEDURE THAT WAS BEING PERFORMED? MULTIPLE PROCEDURES. WAS THERE A MEDICAL PROCEDURE PERFORMED DUE TO THE TORN TISSUE? THERE WAS NOT. WHAT WAS THE PATIENT¿S OUTCOME? HAVE NOT HAD A POOR OUTCOME. WAS THE PROCEDURE COMPLETED AS PLANNED? YES. CAN YOU PLEASE SEND ALL PARTS OF THE INSTRUMENT FOR EVALUATION? YES, IF WE HAVE THE ABILITY TO HAVE A BACKUP PLAN. DO YOU HAVE THE LOT NUMBER? NO. DO YOU HAVE PHOTOS OF THE REPORTED ISSUE ON THE INSTRUMENT? NO, SENT 3 GRASPERS WITH SALES REP FOR EVALUATION. WAS THE PRODUCT RECEIVED IN THIS CONDITION? NOT SURE. HOW MANY INSTRUMENTS HAVE THIS REPORTED ISSUE OF DIFFICULT TO UNLOCK ONCE IN THE LOCKED POSITION? AND ARE YOU RETURNING ALL OF THEM? YES, HOW MANY OF THESE INSTRUMENTS WITH LOCKING ISSUES TORE PATIENT TISSUE? UNSURE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117905 SLIDE-LOCK ROT ATRAU GRASPER DBL-ACT 5MM-NA LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET CAREFUSION, INC 88-8333 C21VEO 10885403154461

    Patients

    Seq Age Sex Outcome Treatment
    1 Other