BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITYONE MUSHROOM CUP

    MDR report key: 10803701 · Received November 6, 2020

    Report

    Report Number
    1216677-2020-00255
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Date of Event
    October 16, 2020
    Report Date
    February 7, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HDB
    UDI-DI
    00888937003123
    PMA / PMN Number
    K890307
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INITIATED MANUFACTURER'S INVESTIGATION, REVIEW DHR, INSPECT RETURNED SAMPLES. DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 5/22 - 5/27-2020 UNDER WORK ORDER 287262. MANUFACTURING RECORD REVIEW: DHR-10067 - 287262 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HISTORY RECORD: SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT PRODUCT WAS RETURNED TO CSI AND CONFIRMED (B)(6) 2021. VISUAL EVALUATION: A VISUAL EVALUATION OF THE COMPLAINT PRODUCT WAS COMPLETED AND CONFIRMED (B)(6) 2021. FUNCTIONAL EVALUATION: AN EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT WAS RETURNED IN A NONFUNCTIONAL MANNER DUE TO REPORTED EVENT, SEE ATTACHED EMAIL WITH PHOTOS. ROOT CAUSE: DEFINITIVE ROOT CAUSE AS TO THE RESULTING REPORTED EVENT IS INDETERMINABLE. PULL TEST SUPPLIER DATA INDICATED ACCEPTABLE RESULTS. CORRECTIVE ACTIONS: NOT APPLICABLE AS THE AFFECTED DEVICES WERE INDIVIDUALLY TESTED BEFORE PACKAGING AND WERE FOUND TO BE ACCEPTABLE. NO FURTHER ACTION IS REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    CUSTOMER REPORTED: ""MD ATTEMPTING VACUUM. BOTH ITEMS BROKE AT THE JUNCTION WHERE THE MUSHROOM CAP MEETS THE LONG PLASTIC ARM". 1216677-2020-00255-1 10067 MITYONE MUSHROOM CUP (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT: "MD ATTEMPTING VACUUM. BOTH ITEMS BROKE AT THE JUNCTION WHERE THE MUSHROOM CAP MEETS THE LONG PLASTIC ARM. PHYSICIAN QUESTIONS IF THE POP OFF MECHANISM WAS WORKING AS SHE FELT IT SHOULD HAVE POPPED OFF INSTEAD OF BREAK." MITYONE MUSHROOM CUP 10067 E-COMPLAINT (B)(4) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262681 MITYONE MUSHROOM CUP MITYONE MUSHROOM CUP HDB COOPERSURGICAL, INC. 10067 287262 00888937003123

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other