BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GASTROSCOPE 9.3/2.8/1100 NTSC

    MDR report key: 17106893 · Received June 12, 2023

    Report

    Report Number
    9610617-2023-00665
    Event Type
    Injury
    Date Received
    June 12, 2023
    Date of Event
    December 13, 2018
    Report Date
    June 9, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FDS
    PMA / PMN Number
    K060907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 20-0074 CORRECTIVE ACTION 6. NO DEVICE MALFUNCTION. THE SALES REPRESENTATIVE OF OUR DISTRIBUTOR (KARL STORZ ENDOSCOPY (UK) LTD, 415 PERTH AVENUE, SLOUGH, BERKSHIRE. UK. SL1 4TQ) MADE A WRONG STATEMENT. THE REPROCESSING INSTRUCTION GIVEN IN THE IFU HAS BEEN REVIEWED AND FOUND TO BE APPLICABLE. GREASE, IN OPPOSITION TO THE STATEMENT, IS NOT RECCOMMENDED - INSTRUMENT OIL IS USED FOR THE SEALING OF THE LEAK TESTER ONLY. RE-TRAINING OF THE SALES REPRESENTATIVE VIA KARL STORZ ENDOSCOPY (UK), AS WELL AS RE-TRAINING FOR RE-PROCESSING AT (B)(6)HOSPITAL. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS EVENT WITH A GASTROSCOPE 9.3/2.8/1100 NTSC. ACCORDING TO THE INFORMATION RECEIVED, THE DEPUTY DECONTAMINATION MANAGER OF THE FACILITY STATED THE FOLLOWING: "ON READING THE IFU WE ASKED THE STORZ ENDOSCOPIC SALES SPECIALIST FOR TRAINING ON THE CORRECT DECONTAMINATION METHOD. WE QUERIED THE DECONTAMINATION OF THE EQUIPMENT AS THE LITERATURE STATED THAT SPECIFIC CLEANING BRUSHES WERE REQUIRED AND ALSO SOME INSTRUMENTATION WAS REQUIRED TO BE GREASED. THIS MAY CAUSE AN ISSUE WITH OUR STERILISATION EQUIPMENT. WE CONTACTED THE ENDOSCOPIC SALES SPECIALIST HE ADVISED THAT BRUSHES AND THE GREASE WERE NOT REQUIRED. WE RAISED THE POINT THAT THIS WAS GOING AGAINST MANUFACTURER'S IFUS AND HE CONFIRMED VIA EMAIL THAT HE WAS ADVISING US TO GO AGAINST THESE INSTRUCTIONS. THIS ADVICE IS TOTALLY CONTRADICTORY AND IT IS A RISK TO PATIENT AND STAFF SAFETY. ALTHOUGH A DECONTAMINATION CERTIFICATE HAS BEEN PROVIDED BY THE PREVIOUS USER WE CANNOT BE ASSURED IT WAS CORRECTLY DECONTAMINATED." DETAILS OF INJURY (TO PATIENT, CARER OR HEALTHCARE PROFESSIONAL): NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275934 GASTROSCOPE 9.3/2.8/1100 NTSC GASTROSCOPE 9.3/2.8/1100 NTSC FDS KARL STORZ SE & CO. KG 13821NKS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other