BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7FR 300CM BIPOLAR HEMO PROBE

    MDR report key: 7425092 · Received April 12, 2018

    Report

    Report Number
    1320894-2018-00083
    Event Type
    Injury
    Date Received
    April 12, 2018
    Report Date
    April 12, 2018
    Manufacturer
    CONMED CORPORATION
    Product Code
    FEH
    UDI-DI
    00653405046991
    PMA / PMN Number
    K803214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USED DEVICE WAS RETURNED TO CONMED WITH ORIGINAL PRODUCT PACKAGING. UPON VISUAL INSPECTION, THE DEVICE WAS OBSERVED TO BE MISSING, AT THE DISTAL TIP OF THE PROBE, A PIECE OF SILVER EPOXY. THE CAUSE OF THE DEFECT WAS NOT DETERMINED DURING INSPECTION; POTENTIALLY THIS DEFECT WAS A RESULT OF DAMAGE TO THE DEVICE. A REVIEW OF THE MANUFACTURING DOCUMENTS VERIFIED THE DEVICE WAS PRODUCED PER CURRENT AND APPROVED PROCEDURES AND MATERIAL SPECIFICATIONS. NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY, EFFECTIVENESS OR PERFORMANCE WERE NOT IDENTIFIED AT THE TIME OF MANUFACTURE. A REVIEW OF THIS LOT NUMBER, WITH (B)(4) MANUFACTURED, SHOWED NO OTHER COMPLAINTS FOR THIS LOT PRODUCT AND EVENT DESCRIPTION. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED NO OTHER SIMILAR COMPLAINTS FOR THIS PRODUCT FAMILY AND FAILURE MODE. (B)(4). A RISK ANALYSIS WAS PERFORMED AND FOUND THIS FAILURE MODE AND OCCURRENCE LEVEL TO BE CONSISTENT AND ACCEPTABLE WITH PREDICTED POST-MARKET RISK. THE INSTRUCTIONS FOR USE ADVISES THE USER OF THE FOLLOWING. USE THE LOWEST POSSIBLE POWER SETTING ON THE CONMED BICAP ELECTROSURGICAL GENERATOR CAPABLE OF ACHIEVING THE DESIRED SURGICAL EFFECT AND TO USE THE SHORTEST EFFECTIVE ACTIVATION TIME NECESSARY. THESE DEVICES SHOULD NEVER BE USED WHEN: THERE IS VISIBLE EVIDENCE OF DAMAGE TO THE EXTERIOR OF THE DEVICE, SUCH AS CUTS, PUNCTURES, NICKS ABRASIONS, UNUSUAL LUMPS OR SIGNIFICANT DISCOLORATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE CONMED SALES REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT THE TIP OF BP-7300A BROKE OFF DURING A PROCEDURE. UPON GATHERING ADDITIONAL INFORMATION, THE USER FACILITY REPORTED THE DISTAL TIP OF THE DEVICE BECAME DETACHED DURING CAUTERY. THE PROCEDURE WAS COMPLETED WITH SURGICAL DELAYS DUE TO THE RETRIEVAL OF AN ALTERNATE DEVICE. THE PATIENT HAS BEEN DISCHARGED SINCE THIS INCIDENT AND DID NOT REQUIRE ADDITIONAL TREATMENT OR HOSPITAL STAY. THE BROKEN PIECE WAS NOT RETRIEVED AND IT WAS LEFT IN THE PATIENT'S STOMACH. THIS REPORT IS BEING RAISED ON THE BASIS OF A NON IMPLANTABLE PIECE OF A DEVICE DETACHING AND LEFT INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269948 7FR 300CM BIPOLAR HEMO PROBE BICAP MULTIELECTRODE BIPOLAR FEH CONMED CORPORATION 201710091 00653405046991

    Patients

    Seq Age Sex Outcome Treatment
    1 Other