BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG. SINGLE SPIKE TUBE SET

    MDR report key: 21642203 · Received March 19, 2025

    Report

    Report Number
    0002936485-2025-00220
    Event Type
    Malfunction
    Date Received
    March 19, 2025
    Date of Event
    February 19, 2025
    Report Date
    August 22, 2025
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    UDI-DI
    37613327061353
    PMA / PMN Number
    K963646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: NEED TO REPORT AN INCIDENT WITH SUCTION/IRRIGATION AT (B)(6) MEDICAL CENTER THIS MORNING. AFTER OPENING PN: 250-070-530, STAFF NOTICED WHAT LOOKS LIKE A PIECE OF GLOVE IN THE PACKAGING. THE PRODUCT DID MAKE IT TO THE STERILE FIELD BUT IT WAS REMOVED PRIOR TO ANY USE. NO MAJOR DELAYS INCURRED. THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PROBABLE ROOT CAUSES COULD BE CONTAMINANTS FELL IN DURING PACKAGING. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE PACKAGING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER OPENING PN: 250-070-530, THE STAFF NOTICED WHAT LOOKS LIKE A PIECE OF GLOVE IN THE PACKAGING. THE PRODUCT DID MAKE IT TO THE STERILE FIELD BUT IT WAS REMOVED PRIOR TO ANY USE. NO MAJOR DELAYS INCURRED. THEREFORE, WAS FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899648 PKG. SINGLE SPIKE TUBE SET ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 24297FG2 37613327061353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown