BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPLORA CURETTE 3MM WITH

    MDR report key: 7022469 · Received November 10, 2017

    Report

    Report Number
    1216677-2017-00067
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    September 26, 2017
    Report Date
    February 28, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HHK
    PMA / PMN Number
    K001545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION FINDINGS AND ANALYSIS: THE DESCRIBED EVENT CANNOT BE FULLY DETERMINED IF IT REFERS TO THE SLIDER SITE MARKER THAT IS SNAPPED ONTO THE CANNULA, OR THE ON THE BARREL SYRINGE THAT ENGAGES WITH THE PLUNGER FOR A CERTAIN AMOUNT OF TRAVEL WITHIN THE BARREL. BOTH ARE ASSEMBLED AND PACKAGED AT CSI TRUMBULL, BUT EACH PLAYS A SEPARATE ROLL AND THEY'RE BOTH FUNCTIONALLY VERIFIED FOR ACCEPTABILITY. FOR REFERENCE SEE THE ATTACHED METHOD SHEET PAGES WHERE EACH IS IDENTIFIED FOR ASSEMBLY INSTRUCTION. THE SLIDER MARKER IS INTENDED TO BE USED AS A DEPTH MARKER AS IT'S DESCRIPTION IMPLIES, AND IS DESIGNED TO MOVE WITH MINIMAL APPLIED FORCE. THE SYRINGE LOCK PREVENTS THE PLUNGER FROM BEING FULLY DEPLOYED AT A PREDETERMINED VOLUME MARKING. WITHOUT THE ACTUAL DEVICE BEING RETURNED FOR INVESTIGATIVE ANALYSIS, A DEFINED ROOT CAUSE CANNOT BE DEFINED AND THEREFORE CONSIDERED INDETERMINABLE. BASED ON THE LIMITED EVENT INFORMATION PROVIDED, IT'S POSSIBLE THAT THE REPORTED EVENT WAS THE RESULT OF USE CONTRA TO IFU (INSTRUCTIONS FOR USE). HOWEVER, IF THE DEVICE IS RETURNED IN THE FUTURE, THE COMPLAINT MAY BE REOPENED AND ADDRESSED AS NEEDED. REVIEW OF THE DHR HAS INDICATED THAT ALL MANUFACTURING AND ASSEMBLY INSTRUCTIONS WERE FOLLOW, NO ABNORMALITIES WERE FOUND. ALL LOT INVENTORY HAS BEEN DEPLETED AND NO LONGER AVAILABLE FOR FURTHER REVIEW. CORRECTIVE ACTIONS: CORRECTIVE ACTION IS NOT APPLICABLE DUE TO THE ABSENCE OF THE ACTUAL AFFECTED DEVICE FOR INVESTIGATIVE ANALYSIS AS IT WAS NOT RETURNED, TO DETERMINE A POSSIBLE ROOT CAUSE. THE COMPLAINT WILL BE MONITORED FOR TRENDING.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED DURING PROCEDURE "STOPPER DID NOT STOP AND INSERTED ITSELF INTO THE PATIENT," "THEY WILL RETRIEVE THE STOPPER DURING THE ALREADY SCHEDULED SURGERY." (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: *ANALYSIS AND FINDINGS: THE DESCRIBED EVENT CANNOT BE FULLY DETERMINED IF IT REFERS TO THE SLIDER SITE MARKER THAT IS SNAPPED ONTO THE CANNULA, OR THE ON THE BARREL SYRINGE THAT ENGAGES WITH THE PLUNGER FOR A CERTAIN AMOUNT OF TRAVEL WITHIN THE BARREL. BOTH ARE ASSEMBLED AND PACKAGED AT CSI TRUMBULL, BUT EACH PLAYS A SEPARATE ROLL AND THEY'RE BOTH FUNCTIONALLY VERIFIED FOR ACCEPTABILITY. THE SLIDER MARKER IS INTENDED TO BE USED AS A DEPTH MARKER AS IT'S DESCRIPTION IMPLIES, AND IS DESIGNED TO MOVE WITH MINIMAL APPLIED FORCE. THE SYRINGE LOCK PREVENTS THE PLUNGER FROM BEING FULLY DEPLOYED AT A PREDETERMINED VOLUME MARKING. WITHOUT THE ACTUAL DEVICE BEING RETURNED FOR INVESTIGATIVE ANALYSIS, A DEFINED ROOT CAUSE CANNOT BE DEFINED AND THEREFORE CONSIDERED INDETERMINABLE. BASED ON THE LIMITED EVENT INFORMATION PROVIDED, IT'S LIKELY THAT THE REPORTED EVENT WAS THE RESULT OF USE CONTRA TO IFU INSTRUCTION FOR USE. HOWEVER, IF THE DEVICE IS RETURNED IN THE FUTURE, THE COMPLAINT MAY BE REOPENED AND ADDRESSED AS NEEDED. REVIEW OF THE DHR HAS INDICATED THAT ALL MANUFACTURING AND ASSEMBLY INSTRUCTIONS WERE FOLLOW, NO ABNORMALITIES WERE FOUND. ALL LOT INVENTORY HAS BEEN DEPLETED AND NO LONGER AVAILABLE FOR FURTHER REVIEW. CORRECTIVE ACTIONS: *CORRECTION AND/OR CORRECTIVE ACTION: CORRECTIVE ACTION IS NOT APPLICABLE DUE TO THE ABSENCE OF THE ACTUAL AFFECTED DEVICE FOR INVESTIGATIVE ANALYSIS AS IT WAS NOT RETURNED, TO DETERMINE A POSSIBLE ROOT CAUSE. REASON: PER (B)(4), THIS COMPLAINT WILL BE MONITORED FOR TRENDING IN THAT NO INJURY WAS REPORTED TO END USER OR PATIENT. *WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 1

    *WHAT ARE THE DETAILS OF THE COMPLAINT? IS THERE ANYTHING ELSE? THE DOCTOR WAS DOING A PROCEDURE, BUT THE STOPPER DID NOT STOP AND INSERTED ITSELF INTO THE PATIENT. THE SYRINGE AND THE CURETTE PERFORMED CORRECTLY ONLY THE STOPPER. *WAS THERE ANY ADDITIONAL MEDICAL ATTENTION? THEY WILL RETRIEVE THE STOPPER DURING THE ALREADY SCHEDULED SURGERY (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802455 EXPLORA CURETTE 3MM WITH EXPLORA CURETTE 3MM WITH HHK COOPERSURGICAL, INC. MX120 204002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O