BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N20 HAMMHD RET PBE STRT

    MDR report key: 15130351 · Received July 29, 2022

    Report

    Report Number
    1216677-2022-00219
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    July 11, 2022
    Report Date
    July 29, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HQA
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: X-REVIEW DHR X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS COMPLAINT (B)(4). DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 03/13/2014 UNDER WORK ORDER (B)(4) AND SOLD ON 05/09/2014. MANUFACTURING RECORD REVIEW: DHR-163103 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NO SERVICE HISTORY RECORD FOUND FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DID NOT SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG (B)(4) THIS UNIT WAS AT CSI ON 07/13/2022. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED PHYSICAL DAMAGE. THE TIP HAD MATERIAL BUILD-UP AND WAS TARNISHED. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND TO NOT FUNCTION PROPERLY. ROOT CAUSE: THE ROOT CAUSE OF THIS ISSUE HAS BEEN ATTRIBUTED TO THE CUSTOMER NOT CLEANING THE TIP PROPERLY. CORRECTION AND/OR CORRECTIVE ACTION THE TIP WAS CLEANED AND POLISHED. THE UNIT WAS TESTED AND FOUND ACCEPTABLE. THE UNIT WAS RETURNED TO THE CUSTOMER. NO FURTHER TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? YES. PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION.

    Description of Event or Problem · 0

    BLACK SPECS COMING OFF PROBE TIP INTO PATIENTS EYE. FS LOG# 98765 1216677-2022-00219 N20 HAMMHD RET PBE STRT 144 E-COMPLAINT-(B)(4).

    Description of Event or Problem · 0

    BLACK SPECS COMING OFF PROBE TIP INTO PATIENTS EYE. FS LOG# (B)(4). 1216677-2022-00219 N20 HAMMHD RET PBE STRT 144 E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1115876 N20 HAMMHD RET PBE STRT N20 HAMMHD RET PBE STRT HQA COOPERSURGICAL, INC. 144 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other