BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCISSORS,SINGLE ACTION

    MDR report key: 13667354 · Received March 4, 2022

    Report

    Report Number
    1216677-2022-00059
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    December 25, 2021
    Report Date
    August 25, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HFB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENLTY INVESTIGATING THE REPORTED CONDITON.

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-NO SAMPLE RETURNED ANALYSIS AND FINDINGS DISTRIBUTION HISTORY, THE COMPLAINT PRODUCT WAS PURCHASED FROM REDA INSTRUMENT - GMBH. MANUFACTURING RECORD REVIEW MANUFACTURING RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. INCOMING INSPECTION REVIEW A REVIEW OF THE INCOMING INSPECTION RECORD COULD NOT BE PERFORMED BECAUSE THE COMPLAINT PRODUCT LOT/SERIAL NUMBER WAS NOT PROVIDED. SHOULD THE COMPLAINT PRODUCT LOT/SERIAL NUMBER BE PROVIDED GOING FORWARD, THE INCOMING INSPECTION REPORT WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. SERVICE HISTORY RECORD SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. ROOT CAUSE ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. CORRECTION AND/OR CORRECTIVE ACTION NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    ES-SCIS MALFUNCTIONING, DON'T CUT JUST 1 USE AND IT WAS BROKEN. RESPONSE- DID THE PHYSICIAN PERFORM ANY EXTRA STEP TO COMPLETE THE PROCEDURE/HOW DID PHYSICIAN COMPLETE THE PROCEDURE/? HE COMPLETED WITH ANOTHER INSTRUMENT, IN THIS CASE A FORCED. WAS THERE ANY SIGNIFICANT DELAY (30 MINS) AS RESULT OF THE REPORTED CONDITION? YES IT WAS, THEY HAD TO CHANGE THE INSTRUMENT AND STOP THE PROCEDURE. 1216677-2022-00059 SCISSORS SINGLE ACTION ES-SCIS E-COMPLAINT-(B)(4).

    Description of Event or Problem · 0

    ES-SCIS MALFUNCTIONING, DON'T CUT JUST 1 USE AND IT WAS BROKEN. RESPONSE- DID THE PHYSICIAN PERFORM ANY EXTRA STEP TO COMPLETE THE PROCEDURE/HOW DID PHYSICIAN COMPLETE THE PROCEDURE/? HE COMPLETED WITH ANOTHER INSTRUMENT, IN THIS CASE A FORCED. WAS THERE ANY SIGNIFICANT DELAY (30 MINS) AS RESULT OF THE REPORTED CONDITION? YES IT WAS, THEY HAD TO CHANGE THE INSTRUMENT AND STOP THE PROCEDURE. 1216677-2022-00059 SCISSORS SINGLE ACTION ES-SCIS E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708891 SCISSORS,SINGLE ACTION SCISSORS,SINGLE ACTION HFB COOPERSURGICAL, INC. ES-SCIS NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other