BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCISSORS, POINTED, 5 FR., 34 CM

    MDR report key: 22680021 · Received July 31, 2025

    Report

    Report Number
    9610617-2025-01331
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Report Date
    March 31, 2026
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    GCJ
    UDI-DI
    04048551094471
    PMA / PMN Number
    K935071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES IN QUESTION (26159SHW, LOT: PQ03; 26159SHW, LOT: XL02; 26159SHW, LOT: NK04 ) WERE RECEIVED BY THE MANUFACTURING SITE IN GERMANY FOR INVESTIGATION. THE ERROR DESCRIBED BY THE CUSTOMER "SCISSORS BROKEN" COULD BE CONFIRMED. HOWEVER, ANALYSIS OF THE INSTRUMENTS REVEALS SEVERE CORROSION, IN PARTICULAR PITTING ON THE SCISSOR BLADE AND CORROSION AT THE DISTAL END. THESE TYPES OF DAMAGE ARE TYPICAL OF MULTIPLE IMPROPER REPROCESSING CYCLES, ESPECIALLY WHEN DRYING IS INSUFFICIENT. IN COMBINATION WITH MECHANICAL OVERUSE, THIS CAN NEGATIVELY AFFECT MATERIAL INTEGRITY AND LEAD TO BREAKAGE. THE COMPLAINT IS MOST LIKELY DUE TO IMPROPER HANDLING AND FAULTY REPROCESSING. THE INVESTIGATION DID NOT REVEAL ANY ROOT CAUSE RELATED TO THE DEVICE DESIGN, LABELING, OR MANUFACTURING PROCESS. ALL QUALITY CONTROL MEASURES WERE MET, AND NO NON-CONFORMITIES WERE FOUND IN THE PRODUCTION RECORDS. IN ADDITION, WE WANT TO DRAW YOUR ATTENTION TO PAGE 7 OF THE CORRESPONDING INSTRUCTION FOR USE (DOCUMENT ID: (B)(4) - (B)(6) 2017)) WHICH INCLUDES A WARNING UNDER SECTION 4.5 "ASSEMBLY, INSPECTION AND CARE" ADVISING TO VISUALLY INSPECT THE CLEANED AND DISINFECTED MEDICAL DEVICE FOR CLEANLINESS, COMPLETENESS, DAMAGE AND DRYNESS. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCISSORS BREAK EVEN WHEN USED ONCE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE: MDR 25-1326, 25-1332, 25-1324, 25-1325, 25-1333 AND 25-1334.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526206 SCISSORS, POINTED, 5 FR., 34 CM SCISSORS, POINTED, 5 FR., 34 CM GCJ KARL STORZ SE & CO. KG 26159SHW XL02 04048551094471

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown