BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N20 RETINAL PRB STRAIGHT

    MDR report key: 12924610 · Received December 3, 2021

    Report

    Report Number
    1216677-2021-00270
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    November 4, 2021
    Report Date
    December 3, 2021
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HQA
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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-INITIATED MANUFACTURER'S INVESTIGATION. X-INSPECT RETURNED SAMPLES . INSPECT STOCK PRODUCT: ANALYSIS AND FINDINGS. DISTRIBUTION HISTORY. THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 08-26-10 UNDER WORK ORDER 94870 AND SOLD ON 12-22-10. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE RECORD COULD NOT BE LOCATED AT THE TIME OF THIS INVESTIGATION. HOWEVER, IT SHOULD BE NOTED AT THE TIME OF MANUFACTURE RECORDS FROM EACH LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL COOPERSURGICAL QUALITY RELEASE SPECIFICATIONS. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD, IT WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. INCOMING INSPECTION REVIEW: INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HISTORY RECORD THIS PRODUCT WAS RETURNED ON 08-03-16 FOR FS LOG 83077 (LEAKING BOILER, LOW FLOW, DRIED SILICONE). HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. THE HISTORY SHOWED ADDITIONAL INSTANCES OF BOTH REPORTED LEAKS AND WORN SEATING (SPRING HOUSING). THESE CONDITIONS WERE USUALLY ATTRIBUTED TO WEAR AND TEAR. PRODUCT RECEIPT: THE COMPLAINT PRODUCT (P/N 124 S/N, 081002) WAS RETURNED ON 11-11-21. THE SERIAL NUMBER OF THE RETURNED PRODUCT MATCHED THE SERIAL NUMBER REPORTED. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT PRODUCT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ALTHOUGH THERE WAS NO LEAK IN THE PROBE, THE HIGH FREEZE FLOW DUE TO WARPING OF THE SPRING HOUSING PREVENTED THE UNIT FROM FUNCTIONING PROPERLY AND REQUIRED ADJUSTMENT. WAS THE COMPLAINT CONFIRMED? NO. ROOT CAUSE. WHILE NO DEFINITIVE ROOT CAUSE COULD BE RELIABLY DETERMINED, THE POTENTIAL CAUSE MAY BE WEAR AND TEAR BASED ON THE AGE OF THE UNIT. CORRECTION AND/OR CORRECTIVE ACTION. THE COMPLAINT UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION.

    Description of Event or Problem · 0

    CORD LEAKING, NOT DROPPING TEMP. FOUND FREEZE FLOW 18.5 MM. REPAIR ORDER #: (B)(6) RETINAL PRB STRAIGHT 124. E-COMPLAINT (B)(4).

    Description of Event or Problem · 0

    CORD LEAKING, NOT DROPPING TEMP. FOUND FREEZE FLOW 18.5 MM. REPAIR ORDER #: 97364. 1216677-2021-00270 N20 RETINAL PRB STRAIGHT 124 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819783 N20 RETINAL PRB STRAIGHT N20 RETINAL PRB STRAIGHT HQA COOPERSURGICAL, INC. 124 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other