BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    800-SERIES

    MDR report key: 10111257 · Received June 2, 2020

    Report

    Report Number
    3012068831-2020-00005
    Event Type
    Malfunction
    Date Received
    June 2, 2020
    Report Date
    January 5, 2022
    Manufacturer
    GETINGE IC PRODUCTION POLAND SP. Z O.O.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF A CUSTOMER PRODUCT COMPLAINT INCLUDING ALLEGATION OF SHARP EDGES FOUND ON STERILIZER'S ACCESSORIES, NAMELY CARTS DESIGNATED TO BE USED WITH 833HC-E STERILIZER. THE ISSUE WAS IDENTIFIED ON SEVERAL CARTS USED WITH FOUR (4) DIFFERENT STEAM STERILIZERS OF THE SAME MODEL OWNED BY THIS SPECIFIC CUSTOMER. AS WE WERE NOT ABLE TO NARROW THE EVENT TO ONE MEDICAL DEVICE ONLY, WE HAVE DECIDED TO REPORT ALL 4 MEDICAL DEVICES SEPARATELY. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS USAGE OF CARTS WITH EXPOSED SHARP EDGES MIGHT BRING ON A HAZARDOUS SITUATION FOR THE USER. THE SHARP EDGES ON CARTS WERE VERIFIED BY A GETINGE EMPLOYEE. ONE OF THE AFFECTED CART WAS RETURNED TO GETINGE FOR FURTHER EVALUATION. IT WAS DECIDED THAT THE REWORK OF CARTS WILL BE DONE TO REMOVE SHARP EDGES AT THIS CUSTOMER. THE REPAIRS ARE COMPLETED AND CARTS COULD BE USED WITHOUT ANY OBJECTIONS. WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUES WE WERE NOT ABLE TO FIND ANY SIMILAR REPORTABLE COMPLAINTS WHERE THE SHARP EDGES ON CARTS USED WITH 833HC-E STERILIZERS LED TO ANY KIND OF INJURY. WHEN THE EVENT OCCURRED, THE DEVICE DID NOT MEET ITS SPECIFICATION DUE TO SHARP EDGES WERE FOUND ON CARTS AND CONTRIBUTED TO THE EVENT. THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT WHEN THE EVENT TOOK PLACE. BASED ON THE PERFORMED ROOT CAUSE ANALYSIS AND INPUT FROM SUBJECT MATTER EXPERT DESIGN SPECIFICATION REQUIRES SUPPLIER TO DEBURR ALL EDGES. IN THIS CASE, SOME OF THE EDGES MIGHT HAVE BEEN SHARPER THAN EXPECTED DUE TO SUPPLIER ERROR. SUPPLIER WAS INFORMED ABOUT THE PROBLEMS AND IMPLEMENTED CORRECTIVE ACTIONS. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION TOWARDS THE DEVICES ON THE MARKET, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    ISSUE IS BEING INVESTIGATED BY THE MANUFACTURING SITE. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON 13TH MAY, 2020 GETINGE BECAME AWARE OF A CUSTOMER PRODUCT COMPLAINT INCLUDING ALLEGATION OF SHARP EDGES FOUND ON STERILIZER'S ACCESSORIES, NAMELY CARTS DESIGNATED TO BE USED WITH 833HC-E STERILIZER. THE ISSUE WAS IDENTIFIED ON SEVERAL CARTS USED WITH  FOUR (4) DIFFERENT STEAM STERILIZERS OF THE SAME MODEL OWNED BY THIS SPECIFIC CUSTOMER. AS WE WERE NOT ABLE TO NARROW THE EVENT TO ONE MEDICAL DEVICE ONLY, WE HAVE DECIDED TO REPORT ALL 4 MEDICAL DEVICES SEPARATELY. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS USAGE OF CARTS WITH EXPOSED SHARP EDGES MIGHT BRING ON A HAZARDOUS SITUATION FOR THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575580 800-SERIES STERILIZER, STEAM FLE GETINGE IC PRODUCTION POLAND SP. Z O.O. 833HC-E

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown