BEUDAMED
    FDA Adverse Event Death Summary report: N

    TOUCHSOFT COAGULATOR

    MDR report key: 21517346 · Received March 4, 2025

    Report

    Report Number
    1220592-2025-00001
    Event Type
    Death
    Date Received
    March 4, 2025
    Date of Event
    December 17, 2024
    Report Date
    March 4, 2025
    Manufacturer
    HOBBS MEDICAL, INC.
    Product Code
    KNS
    UDI-DI
    M849G11200400
    PMA / PMN Number
    K093079
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING RECORDS COULD NOT BE REVIEWED AS THE FACILITY WAS NOT ABLE TO PROVIDE LOT INFORMATION FOR THE DEVICE INVOLVED IN THE EVENT. PER THE DESCRIPTION OF THE PROCEDURE PROVIDED BY THE FACILITY, GENERATOR SETTINGS USED WERE WITHIN THE PARAMETERS RECOMMENDED IN THE IFU.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HOSPITAL "HAD A PATIENT THAT HAD 2 DUODENAL AVMS, FOR WHICH THE TOUCHSOFT PROBE WAS USED. THE SETTINGS WERE APPROPRIATE, WITH IT BEING ON SOFT COAG. AND AT 30-40 WATTS. THE COAGULATION APPEARED TO BE APPROPRIATE. THE PATIENT WAS DISCHARGED, AND A DAY LATER WAS HAVING ABDOMINAL PAIN. THE PATIENT HAD A DUODENAL PERFORATION REQUIRING SURGERY." UPON FOLLOW-UP, THE HOSPITAL EXPLAINED, TWO DAYS AFTER THE SURGERY, THE PATIENT CALLED THE DOCTOR COMPLAINING ABOUT PAIN. THE PATIENT RETURNED TO THE HOSPITAL, AND THE DOCTOR FOUND AN INFECTION IN THE DUODENUM. THE PATIENT WAS ADMITTED TO THE HOSPITAL WHERE A CT SCAN WAS PERFORMED, AND A PERFORATION WAS FOUND. THE PATIENT WAS TAKEN TO SURGERY AND THEN WAS ADMITTED TO THE ICU, WHERE THE PATIENT REMAINED FOR SIX WEEKS UNTIL PASSING AWAY. IN ADDITION, THE HOSPITAL REPRESENTATIVE STATED THAT THE PATIENT HAD SEVERAL OTHER CO-MORBIDITIES AND DID NOT KNOW EXACTLY WHAT CAUSED THIS EVENT TO HAPPEN. THE HOSPITAL REPRESENTATIVE STATED THAT THE DOCTOR DID NOT THINK THAT THE PROBE CONTRIBUTED TO THE PATIENT'S PASSING BUT CANNOT RULE IT OUT. AVMS WERE 2 SMALL, NONBLEEDING ANGIODYSPLASIAS LOCATED IN THE SECOND PORTION OF THE DUODENUM. TOUCHSOFT PROBE SETTINGS USED WERE 30, INCREASED TO 40 DURING TREATMENT. NO ABNORMALITIES WERE NOTED DURING TREATMENT. PATIENT ALSO RECEIVED BIOPSY OF 10MM NODULE IN DUODENAL BULB. PERFORATION WAS LOCATED IN THIRD PORTION OF THE DUDENUM PER OPERATIVE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2480193 TOUCHSOFT COAGULATOR ENDOSCOPIC MONOPOLAR ELECTROSURGICAL COAGULATOR KNS HOBBS MEDICAL, INC. G11-200-40 M849G11200400

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| D| R| H ERBE ELECTROSURGICAL GENERATOR