BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RI WITNESS,SIT ON TOP,

    MDR report key: 10283319 · Received July 16, 2020

    Report

    Report Number
    1216677-2020-00146
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Date of Event
    June 29, 2020
    Report Date
    September 23, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    MQG
    PMA / PMN Number
    K160504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: X-NO SAMPLE RETURNED. X-REVIEW DHR. ANALYSIS AND FINDINGS: DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 11/02/2020. MANUFACTURING RECORD REVIEW: DHR 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 DID NOT SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL AS THIS IS A FIELD SERVICE COMPLAINT. VISUAL EVALUATION/FUNCTIONAL EVALUATION: THIS IS A FIELD SERVICE COMPLAINT, THERE WAS NO PRODUCT RETURNED FOR EVALUATION. IF FURTHER INFORMATION BECOMES AVAILABLE AT A LATER DATE THIS INVESTIGATION WILL BE AMENDED ACCORDINGLY. ROOT CAUSE: THIS IS A FIELD SERVICE COMPLAINT, THERE WAS NO PRODUCT RETURNED FOR EVALUATION. IF FURTHER INFORMATION BECOMES AVAILABLE AT A LATER DATE THIS INVESTIGATION WILL BE AMENDED ACCORDINGLY. ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED AT THIS TIME BUT LIKELY ROOT CAUSE CAN BE ATTRIBUTED TO CUSTOMER ERROR. CORRECTION AND/OR CORRECTIVE ACTION: NONE. REASON: NO FURTHER TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? NO, THIS COMPLAINT WAS ADDRESSED IN THE FIELD, THE TECHNICIAN PERFORMED THE FOLLOWING: POWER SUPPLIES REPLACED. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

    Description of Event or Problem · 0

    REPORT SUBMITTED BY RI- PER FCIF "A COUPLE OF THE EMBRYOLOGISTS HAVE MENTIONED TO ME TODAY THAT THEY GET A SMALL ELECTRIC SHOCK FROM THE METAL STRIP AT THE BASE OF THE RI WITNESS PLATES, IF THEY REST THEIR ARM AT THE EDGE OF THE PLATE. THIS SEEMS TO BE AFFECTING THE LEFT SIDE OF THE ICSI HOOD AND THE RIGHT SIDE OF THE FREEZING HOOD." THE UNIT IS PLUGGED DIRECTLY TO THE LAB WALL SOCKET. (NOT VIA ANY OTHER EQUIPMENT) AN ENGINEER HAS BEEN PREPPED BY THE DESIGN TEAM TO VISIT AND FAULT FIND. REF: (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. REFERENCE: E-COMPLAINT-(B)(4).

    Description of Event or Problem · 1

    REPORT SUBMITTED BY RI- PER FCIF "A COUPLE OF THE EMBRYOLOGISTS HAVE MENTIONED TO ME TODAY THAT THEY GET A SMALL ELECTRIC SHOCK FROM THE METAL STRIP AT THE BASE OF THE RI WITNESS PLATES, IF THEY REST THEIR ARM AT THE EDGE OF THE PLATE. THIS SEEMS TO BE AFFECTING THE LEFT SIDE OF THE ICSI HOOD AND THE RIGHT SIDE OF THE FREEZING HOOD." THE UNIT IS PLUGGED DIRECTLY TO THE LAB WALL SOCKET. (NOT VIA ANY OTHER EQUIPMENT) AN ENGINEER HAS BEEN PREPPED BY THE DESIGN TEAM TO VISIT AND FAULT FIND. REF: E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745853 RI WITNESS,SIT ON TOP, RI WITNESS,SIT ON TOP, MQG COOPERSURGICAL, INC. 6-70-807 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other