BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 12962996 · Received December 8, 2021

    Report

    Report Number
    1216677-2021-00277
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    November 12, 2021
    Report Date
    April 12, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION. X-INITIATED MANUFACTURER'S INVESTIGATION. X-REVIEW DHR. X-INSPECT RETURNED SAMPLES . ANALYSIS AND FINDINGS: DISTRIBUTION HISTORY. THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 02-04-20 UNDER WORK ORDER 281191 AND SOLD ON 09-19-20. MANUFACTURING RECORD REVIEW: DHR-281191 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: NO SERVICE HISTORY RECORD FOUND FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. THERE ARE ADDITIONAL INSTANCES OF DEFROSTING PROBLEMS. THE ROOT CAUSE HAS USUALLY BEEN ATTRIBUTED TO END USER MISHANDLING (SUCH AS COLD SOAKING DURING DECONTAMINATION). PRODUCT RECEIPT: THE COMPLAINT PRODUCT (P/N 900001 S/N (B)(6) ) WAS RETURNED ON 11/23/21. 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. A STUCK PULSE PISTON WAS PREVENTING THE UNIT FROM DEFROSTING PROPERLY. WAS THE COMPLAINT CONFIRMED? YES. ROOT CAUSE: WHILE NO DEFINITIVE ROOT CAUSE COULD BE RELIABLY DETERMINED, THE POTENTIAL CAUSE MAY BE IMPROPER CLEANING/STERILIZATION (LIKELY COLD SOAKING THAT CONTAMINATES AND CLOGS THE PULSE PISTON). CORRECTION AND/OR CORRECTIVE ACTION. THE COMPLAINT UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION. NO FURTHER TRAINING REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 0

    DEFROST NOT WORKING. CONFIRMED COMPLAINT: PULSE PISTON STUCK. REPAIR ORDER #: 97422. 1216677-2021-00277 LL100 CRYOSURGICAL 900001 (B)(4).

    Description of Event or Problem · 0

    DEFROST NOT WORKING. CONFIRMED COMPLAINT: PULSE PISTON STUCK. REPAIR ORDER #: (B)(4). LL100 CRYOSURGICAL 900001 E-COMPLAINT- (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856217 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other