BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60MM REINFORCEMENT

    MDR report key: 12070378 · Received June 25, 2021

    Report

    Report Number
    3005075853-2021-03569
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Date of Event
    May 29, 2021
    Report Date
    June 3, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    OXC
    UDI-DI
    10705036023296
    PMA / PMN Number
    K190937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 8/25/2021. ADDITIONAL INFORMATION: THIS IS AN ANALYSIS FOR AN ECH60R SUBMITTED TO ETHICON ENDO-SURGERY FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTOS SHOW ONE PACKAGE THE ECH60R WITH A TRIGGERED TEMPERATURE STICKER. BASED ON THE ECH60R REVIEW, THE EVENT DESCRIBE IS CONFIRMED, HOWEVER, NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. PLEASE REFER TO THE DEVICE ANALYSIS FOR FULL ANALYSIS DETAILS AND CONCLUSION.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 08/02/2021. D4: LOT/BATCH # QGCBQLS0. DEVICE ANALYSIS: THE PRODUCT WAS RETURNED TO ETHICON ENDO SURGERY FOR EVALUATION. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT ONE OPENED, EMPTY CARTON WAS RETURNED WITH A TRIGGERED TEMPERATURE STICKER, INDICATING THE CARTON EXPERIENCED A TEMPERATURE OF 50°C OR GREATER AT SOME POINT IN TIME. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS BATCH NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. AS PART OF ETHICON ENDO SURGERY¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED BASED ON THE RETURNED CONDITION, IT SHOULD BE NOTED THAT THE TEMPERATURE STICKER IS NON-REVERSABLE. WITH NO TEMPERATURE CONTROLLED SHIPPING DURING THE PRODUCT RETURN AND PROCESSING, THERE IS NO WAY TO CONFIRM THE REPORTED CONDITION AT THE TIME OF THE REPORTED EXPERIENCE. ACTIVATION OF THE STICKER IS A FUNCTION OF TEMPERATURE AND TIME AND ANY AMOUNT OF PICK/RED IS CONSIDERED ACTIVATED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE ECH60R; QGCBQLS0 NUMBER AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. MANUFACTURING DATE: 06.08.2020; EXPIRATION DATE: 11.30.2021.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH #: UNKNOWN. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: PLEASE EXPLAIN WHAT IS MEANT BY ¿HEATER INDICATOR DID NOT FUNCTION PROPERLY¿? IT WAS THE THERMAL INDICATOR CHANGE THE PINK. DOES THAT MEAN THAT THE STICKER WAS PIC BUT THE BAM WAS NOT MELTED OR WAS THE BAM MELTED, BUT THE STICKER WAS NOT PINK? IT WAS THE THERMAL INDICATOR CHANGE THE PINK. HOWEVER, WE DO NOT KNOW THE STATUS OF BAM. CAN YOU PLEASE DESCRIBE THE SUPPLY CHAIN, SHIPPING, AND STORAGE CONDITIONS OF THE PRODUCT IN THE COUNTRY AND AT THE FACILITY? SALES RECEIVED IT AS A SAMPLE FOR NON-CLINICAL USE AND CONFIRMED IT WHEN HE TRANSPORTED IT IN HIS PERSONAL CAR TO THE DISTRIBUTOR FOR DEMONSTRATION. ARE ANY PICTURES AVAILABLE OF THE PRODUCT OR THE HEAT INDICATOR PRIOR TO RETURN SHIPMENT? ATTACHED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE HEATER INDICATOR DID NOT FUNCTION PROPERLY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963896 ECHELON 60MM REINFORCEMENT OXC OXC ETHICON ENDO-SURGERY, LLC. QGCBQLS0 10705036023296

    Patients

    Seq Age Sex Outcome Treatment
    1