BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN BIPOL BAY FINE TIP .5MM STR FORCEP

    MDR report key: 10985102 · Received December 10, 2020

    Report

    Report Number
    1423507-2020-00060
    Event Type
    Injury
    Date Received
    December 10, 2020
    Date of Event
    November 20, 2020
    Report Date
    January 22, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    GEI
    UDI-DI
    10885403071751
    PMA / PMN Number
    K811820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP 2135447. THE DEVICE INVOLVED WAS NOT RETURNED FOR EVALUATION. THE THREE PHOTOS PROVIDED WERE OF FAIRLY POOR CONDITION (I.E., BLURRY) AND DID NOT REVEAL ANY RELEVANT OR USEFUL INFORMATION THAT COULD BE USED FOR A COMPLAINT EVALUATION. AS STATED IN THE EVENT DESCRIPTION, ¿IT APPEARS THAT THERE WAS NO ISSUE WITH THE INSTRUMENT, BUT THAT THE TEAM DID NOT REALIZE THE INSTRUMENT BEING USED WAS NOT INSULATED - HAD ANTICIPATED THAT ONLY THE FORCEPS TIP WOULD BE ACTIVATED.¿ BASED ON THIS, IT SOUNDS LIKE A (MIS)USE ERROR, NOT UNDER THE MANUFACTURER¿S CONTROL. THERE HAVE BEEN NO ISSUES IDENTIFIED WITH THE MATERIAL OR MANUFACTURING PROCESS. THE PRODUCT HAS BEEN MANUFACTURED AND TESTED ACCORDING TO THE SPECIFICATIONS. THE REPORTED ISSUE WILL CONTINUE TO BE TRENDED AND EVALUATED BY BD. A REVIEW OF THE BD COMPLAINT SYSTEM WAS PERFORMED FOR THIS INSTRUMENT OVER THE LAST TWO YEARS. THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS WITH THE SUPPLIER FOR THIS REPORTED ISSUE. THE REPORTED ISSUE WILL CONTINUE TO BE TRENDED AND EVALUATED BY BD.

    Description of Event or Problem · 0

    PATIENT LIP WAS BURNED DURING A BASE OF TONGUE BIOPSY BY THE V MUELLER NEURO/SPINE BI-POLAR FORCEPS THAT WAS USED FOR CAUTERY DURING THE PROCEDURE. ALTHOUGH WE ARE JUST BEGINNING TO INVESTIGATE, IT APPEARS THAT THERE WAS NO ISSUE WITH THE INSTRUMENT, BUT THAT THE TEAM DID NOT REALIZE THE INSTRUMENT BEING USED WAS NOT INSULATED - HAD ANTICIPATED THAT ONLY THE FORCEPS TIP WOULD BE ACTIVATED. WE RECOMMEND CONSIDERATION BY THE MANUFACTURER TO -POSSIBLY MARK THE PACKING MORE PROMINENTLY THAT THIS INSTRUMENT IS NOT INSULATED. NO FURTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4) 03DEC2020 WRITER SENT THE CUSTOMER AN EMAIL ACKNOWLEDGING RECEIPT OF THE COMPLAINT, PROVIDING THE COMPLAINT TRACKING NUMBER AND REQUESTED FOLLOW UP INFORMATION INCLUDING AS TO IF THERE WAS ANY PATIENT IMPACT RELATED TO THIS EVENT. WRITER PROVIDED CONTACT INFORMATION. DEVICE NOT YET EVALUATED, IF THE DEVICE IS EVALUATED A FOLLOW UP WILL BE SENT. KIRWAN SURGICAL PRODUCTS, INC IS THE MANUFACTURER OF THIS 1P SUPPLIED PRODUCT, AND HAS BEEN NOTIFIED OF THIS REPORTABLE EVENT. BD DOES NOT OWN THE DESIGN, SPECIFICATION, OR REGULATORY PATHWAY FOR THIS PRODUCT.

    Description of Event or Problem · 1

    PER MEDWATCH: PATIENT LIP WAS BURNED DURING A BASE OF TONGUE BIOPSY BY THE V MUELLER NEURO/SPINE BI-POLAR FORCEPS THAT WAS USED FOR CAUTERY DURING THE PROCEDURE. ALTHOUGH WE ARE JUST BEGINNING TO INVESTIGATE, IT APPEARS THAT THERE WAS NO ISSUE WITH THE INSTRUMENT, BUT THAT THE TEAM DID NOT REALIZE THE INSTRUMENT BEING USED WAS NOT INSULATED - HAD ANTICIPATED THAT ONLY THE FORCEPS TIP WOULD BE ACTIVATED. WE RECOMMEND CONSIDERATION BY THE MANUFACTURER TO -POSSIBLY MARK THE PACKING MORE PROMINENTLY THAT THIS INSTRUMENT IS NOT INSULATED. NO FURTHER INFORMATION AVAILABLE. COMPLAINT NUMBER (B)(4) WAS OPENED AND AN INITIAL MDR WAS SUBMITTED BASED ON A MEDWATCH # (B)(4) WE RECEIVED FOR THE PRODUCT LISTED IN SUSPECT MEDICAL DEVICE AS PRODUCT NUMBER CH6420. HOWEVER, WHEN CLARIFIED WITH THE CUSTOMER WHY IT SAYS ¿V MUELLER WITH THE NEURO/SPINE BI-POLAR FORCEPS¿ IN THE DESCRIPTION, SHE SAID THAT IT WAS SUPPOSED TO BE SUBMITTED FOR NL1552 - TITAN BIPOL BAY FINE TIP .5MM STR FORCEP. WE HAVE OPENED COMPLAINT (B)(4) TO CAPTURE THE CORRECT INSTRUMENT OF NL1552 AND AN MDR FOR THIS PRODUCT WILL BE SUBMITTED. MFR REPORT# 1423507-2020-00055 IS THE FOLLOW UP MDR THAT WAS SUBMITTED FOR COMPLAINT # (B)(4) EXPLAINING THE ERROR REGARDING PRODUCT NUMBER CH6420. 03DEC2020 ADDITIONAL INFORMATION: THE CUSTOMER FIRST MENTIONED ON 20NOV2020 THAT THE FORCEPS (NL1552) WERE IN FACT WHAT WAS SUPPOSED TO BE REPORTED INSTEAD OF PRODUCT # CH6420 REFERENCED IN COMPLAINT # (B)(4), AND THEN IT WAS CONFIRMED ON 23NOV2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449197 TITAN BIPOL BAY FINE TIP .5MM STR FORCEP ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CAREFUSION, INC NL1552 UNKNOWN 10885403071751

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention