BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 19291761 · Received May 10, 2024

    Report

    Report Number
    0002090040-2024-00001
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    October 26, 2022
    Report Date
    October 29, 2024
    Manufacturer
    STRYKER-ENDOSCOPY PHOENIX USA
    Product Code
    NLH
    UDI-DI
    00885825009557
    PMA / PMN Number
    K112232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO "F10 / H6 HEALTH EFFECT - IMPACT CODE" FROM PROLONGED SURGERY TO INSUFFICIENT INFORMATION. CORRECTION TO D4 "EXPIRATION DATE" FROM 08/10/2022 TO 08/10/2024.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. UPON INSPECTION OF THE RECEIVED COMPLAINT DEVICE, THE CATHETER FORMED AN 'S' CURVE WHEN ACTUATING THE CATHETER DEFLECTION KNOB MECHANISM. THE DEVICE DID NOT MEET THE CURVE SPECIFICATION, AND THE DEVICE DID NOT MEET THE PLANARITY SPECIFICATION. THE RESULTS OF THE INVESTIGATION DETERMINED THAT THE REPORTED EVENT WAS CONFIRMED. A REVIEW OF THE DHR SUPPORTS THAT THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE FROM STRYKER. THEREFORE, THE MOST LIKELY ROOT CAUSE IS A CATHETER CURVE FAILURE AS A RESULT OF MISHANDLING SUBSEQUENT TO DISTRIBUTION, INCLUDING SHIPPING AND STORAGE CONDITIONS OR IMPROPER MANIPULATION OF THE DEVICE. THE INSTRUCTIONS FOR USE (IFU) STATE: DO NOT ATTEMPT TO USE THE REPROCESSED EP CATHETER PRIOR TO COMPLETELY READING AND UNDERSTANDING THE DIRECTIONS FOR USE. DO NOT ALTER THIS DEVICE. INSPECT THE PACKAGING AND CATHETER FOR DAMAGE OR DEFECTS PRIOR TO USE. AVOID EXCESSIVE TORQUE, STRETCHING, KINKING AND/OR BENDING OF CATHETER, AS THIS MAY INTERFERE WITH DISTAL TIP SHAPING OR CAUSE DAMAGE TO INTERNAL ELECTRODE WIRES. AVOID MANUAL PRE-BENDING OF DISTAL CURVE, AS THIS MAY DAMAGE STEERING MECHANISM OF STEERABLE CATHETERS. HANDLE CATHETER WITH CARE TO AVOID IMPROPER ELECTRICAL FUNCTIONING. AVOID EXCESSIVE CONTACT OF HANDPIECE WITH FLUIDS, AS THIS COULD ADVERSELY AFFECT THE ELECTRICAL PERFORMANCE OF THE CATHETER. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CURVE WAS DEFECTIVE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CURVE WAS DEFECTIVE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2520390 NA CATHETER, RECORDING, ELECTRODE, REPROCESSED NLH STRYKER-ENDOSCOPY PHOENIX USA 81104 4842924SH 00885825009557

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown