BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NON COATED PNCL RKR HLSTR

    MDR report key: 11747206 · Received April 29, 2021

    Report

    Report Number
    1721194-2021-00031
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    January 1, 2021
    Report Date
    April 9, 2021
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    UDI-DI
    10614559100844
    PMA / PMN Number
    K965054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 5/5/2021. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: ARE THERE ANY PHOTOS OF THE BURN THAT YOU COULD SHARE WITH US IN REGARDS TO THE BURN? IF YES, PLEASE SEND TO [email protected] WHEN WERE THE BURNS FIRST NOTICED? WHAT MEDICAL INTERVENTION WAS USED TO TREAT THE BURN? (SUCH AS SALVE OR STITCHES) ARE THERE ANY ANTICIPATED LONG-TERM EFFECTS FROM THE BURN? WHAT IS THE CURRENT STATUS OF THE PATIENT? HOW WAS THE PATIENT POSITIONED? HOW WAS THE ROOM SET UP TO INCLUDE PATIENT SET UP AND WHERE WAS THE PAD IN RELATION TO THE PATIENT? WAS THERE ANYTHING BETWEEN PATIENT? WAS THE PAD RINSED AND LET DRY BEFORE IT ON THIS SURGICAL PROCEDURE? HOW WAS PAD CLEANED? DOES THE SURGEON BELIEVE THERE IS THERE AN ALLEGED DEFICIENCY TO THE PAD THAT LED TO PATIENT BURN AND IF SO WHY? WAS THE OPERATION ROOM STAFF USING THE PROVIDED HOLSTER TO STORE WHILE THE DEVICE WAS NOT USED. LOCATION OF THE BURN ON PATIENT IN CORRELATION TO THE OPERATING SITE? HOW LONG WAS THE PROCEDURE? WHAT IS THE SIZE AND SHAPE OF BURN? WILL THE DEVICE BE RETURNED FOR ANALYSIS? ANSWER: I HAVE NO FURTHER INFORMATION ON THE DEVICE, AND THE ACCOUNT HAS NOT GIVEN ME THE DEVICE TO SEND BACK. I HAVE NO NEW INFORMATION AT THIS POINT.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: ONLY EVENT YEAR KNOWN: 2021. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: COULD YOU PLEASE CONFIRM WHAT IS THE SEVERITY OF THE BURN? THE ACCT TOLD ME SECOND DEGREE BURNS WAS WHAT THE SURGEON REPORTED. WAS THE PENCIL INSPECTED BEFORE USE? YES. WAS THE DEFECT DISCOVERED BEFORE OR AFTER PENCIL APPLICATION TO THE PATIENT? AFTER. WHAT TYPE OF ELECTROLYTE IRRIGATION SOLUTION WAS USED? NONE USED AT THAT POINT. WAS THE SURGICAL PROCEDURE PERFORMED IN AN OXIDIZER ENRICHED ENVIRONMENT? NO ANSWER. WERE FLAMMABLE AGENTS USED? YES, CHLORO PREP/ANESTHESIA GASSES. WERE THERE ANY BENDS, KINKS, OR KNOTS PRESENT ON THE ELECTROSURGICAL CORED AT THE TIME OF THE DEFECT DISCOVERY? NO. WAS THE PENCIL TESTED PRIOR TO ITS APPLICATION TO THE PATIENT? YES. TYPE OF SURGICAL PROCEDURE BEING PERFORMED? MASTECTOMY. WAS THE ACTIVE ELECTRODE BENT OR MODIFIED AT ANY TIME? NO. WAS A SAFETY HOLSTER USED? IF YES, WHERE WAS IT LOCATED DURING THE PROCEDURE? YES, PATIENT'S SIDE OF THE ABDOMEN ATTACHED TO DRAPE. WHAT WAS THE DURATION OF THE SURGICAL PROCEDURE? 1057-1409. GENERATOR MODEL SN (B)(4) CONMED. GENERATOR POWER SETTINGS 40/40. IS A PHOTO OF AFFECTED SITE AVAILABLE? NO. SIZE OF AFFECTED SITE? ESTIMATED PEN POINT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: ARE THERE ANY PHOTOS OF THE BURN THAT YOU COULD SHARE WITH US IN REGARDS TO THE BURN? IF YES, PLEASE SEND TO (B)(4). WHEN WERE THE BURNS FIRST NOTICED? WHAT MEDICAL INTERVENTION WAS USED TO TREAT THE BURN? (SUCH AS SALVE OR STITCHES) ARE THERE ANY ANTICIPATED LONG-TERM EFFECTS FROM THE BURN? WHAT IS THE CURRENT STATUS OF THE PATIENT? HOW WAS THE PATIENT POSITIONED? HOW WAS THE ROOM SET UP TO INCLUDE PATIENT SET UP AND WHERE WAS THE PAD IN RELATION TO THE PATIENT? WAS THERE ANYTHING BETWEEN PATIENT? WAS THE PAD RINSED AND LET DRY BEFORE IT ON THIS SURGICAL PROCEDURE? HOW WAS PAD CLEANED? DOES THE SURGEON BELIEVE THERE IS THERE AN ALLEGED DEFICIENCY TO THE PAD THAT LED TO PATIENT BURN AND IF SO WHY? WAS THE OPERATION ROOM STAFF USING THE PROVIDED HOLSTER TO STORE WHILE THE DEVICE WAS NOT USED. LOCATION OF THE BURN ON PATIENT IN CORRELATION TO THE OPERATING SITE? HOW LONG WAS THE PROCEDURE? WHAT IS THE SIZE AND SHAPE OF BURN? WILL THE DEVICE BE RETURNED FOR ANALYSIS? IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MASTECTOMY PROCEDURE A PATIENT WAS BURNED AT THE SURGICAL SITE WHILE THE MONOPLANE PENCIL WAS USED. THE CUSTOMER IS KEEPING THE PRODUCT UNTIL THE INCIDENT REPORT IS CLEAR. THEY HAVE ALSO HAD TO CONTACT THE ELECTROSURGICAL GENERATOR COMPANY, MEDTRONIC, TO SEE WHAT STEPS NEED TO BE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642500 NON COATED PNCL RKR HLSTR NON COATED PENCIL ROCKER HOLSTER GEI MEGADYNE MEDICAL PRODUCTS, INC. 0038H 10614559100844

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention