BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOBBS MEDICAL TOUCHSOFT COAGULATOR

    MDR report key: 21548956 · Received March 7, 2025

    Report

    Report Number
    1528319-2025-00013
    Event Type
    Death
    Date Received
    March 7, 2025
    Date of Event
    December 17, 2024
    Report Date
    March 7, 2025
    Manufacturer
    HOBBS MEDICAL, INC.
    Product Code
    KNS
    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

    US ENDOSCOPY IS THE COMPLAINT FILE ESTABLISHMENT AND REPACKAGER/RELABELER FOR THE DEVICE SUBJECT OF THIS EVENT. THE DEVICE IS MANUFACTURED BY HOBBS MEDICAL, INC. AND DISTRIBUTED BY US ENDOSCOPY. ON FOLLOW-UP WITH THE USER FACILITY, US ENDOSCOPY LEARNED THAT THE PATIENT'S MEDICAL HISTORY AND COMORBIDITIES INCLUDED GASTRIC CARCINOID TUMOR, COLONIC POLYPS, RENAL CELL CANCER, HYPERTENSION, AND HYPERLIPIDEMIA. UNRELATED TO USE OF THE TOUCHSOFT COAGULATOR FOR AVM TREATMENT, THE PROCEDURE SUBJECT OF THIS REPORTED EVENT INCLUDED BIOPSY OF A 10MM NODULE IN THE DUODENAL BULB. TWO SMALL NONBLEEDING ANGIODYSPLASIAS WERE ALSO NOTED DURING THE PROCEDURE. THE USER FACILITY STATED THAT THEY DO NOT KNOW EXACTLY WHAT CAUSED THIS EVENT TO HAPPEN; THE DOCTOR STATED HE DID NOT THINK THAT THE PROBE CONTRIBUTED TO THE PATIENT'S PASSING BUT COULD NOT RULE IT OUT. ADDITIONALLY, US ENDOSCOPY LEARNED THAT THE USER FACILITY USED A THIRD PARTY ERBE GENERATOR SET AT 30-40 WATTS WITH THE TOUCHSOFT COAGULATOR DURING THE PROCEDURE. THE SETTING WAS CONTRARY TO THE TOUCHSOFT COAGULATOR INSTRUCTIONS FOR USE (IFU) WHICH STATES, "THE TOUCHSOFT COAGULATOR CAN BE USED WITH...GENERATOR MODEL ERBE, RANGE IN WATTS 45-60." THE IFU STATES, "CAUTION: DO NOT APPLY EXCESSIVE HEAT, FORCE OR PROLONGED APPLICATION TIME, AS THIS MAY CAUSE DAMAGE TO THE DEVICE, STICKING OF THE DEVICE TO THE TISSUE OR OTHER UNDESIRABLE EFFECTS, INCLUDING POSSIBLE PERFORATION." THE IFU FURTHER STATES, "ALWAYS CHOOSE THE LOWEST POWER SETTING AND SHORTEST TIME DURATION (3 SECONDS OR LESS) THAT WILL ACHIEVE THE DESIRED CLINICAL RESULT." THE DEVICE SUBJECT OF THE EVENT WAS DISCARDED BY USER FACILITY PERSONNEL AND IS NOT AVAILABLE FOR EVALUATION. THE USER FACILITY WAS UNABLE TO PROVIDE A LOT NUMBER FOR THE DEVICE SUBJECT OF THE EVENT. A REVIEW OF DISTRIBUTION RECORDS INDICATES THAT THE USER FACILITY HAS ORDERED 5 LOTS OF THIS PRODUCT SINCE 2022. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH ANY OF THESE 5 LOTS. THE IFU INCLUDES THE FOLLOWING WARNINGS AND CAUTIONS, "WARNING: POTENTIAL ADVERSE EFFECTS INCLUDE, BUT ARE NOT LIMITED TO: RISK OF PERFORATION, HEMORRHAGE, INFECTION, THERMAL BURNS, AND EXPLOSION. CAUTION: ONLY THE USER CAN EVALUATE THE CLINICAL FACTORS INVOLVED WITH EACH PATIENT TO DETERMINE IF THE USE OF THIS DEVICE IS INDICATED. THE USER MUST THEN DECIDE ON THE SPECIFIC TECHNIQUE AND PROCEDURE THAT WILL BEST ACCOMPLISH THE DESIRED CLINICAL EFFECT. DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN THE STATED INDICATION FOR USE. WARNING: THE USER MUST THOROUGHLY UNDERSTAND THE TECHNICAL PRINCIPLES, CLINICAL TECHNIQUES AND RISKS ASSOCIATED WITH THE USE OF HIGH FREQUENCY ELECTROSURGICAL ENERGY IN GENERAL AND THE CHARACTERISTICS OF THEIR CHOSEN ELECTROSURGICAL GENERATOR IN PARTICULAR BEFORE USING THIS PRODUCT." A US ENDOSCOPY ACCOUNT MANAGER OFFERED THE USER FACILITY IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE TOUCHSOFT COAGULATOR; HOWEVER, THE USER FACILITY DECLINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT A PATIENT REPORTED ABDOMINAL PAIN AND RETURNED TO THE HOSPITAL ONE DAY AFTER A PROCEDURE WHICH INCLUDED USE OF THE TOUCHSOFT COAGULATOR FOR TREATMENT OF TWO SMALL ARTERIOVENOUS MALFORMATIONS (AVMS) IN THE SECOND PORTION OF THE DUODENUM. UPON RETURN TO THE HOSPITAL, THE PATIENT WAS FOUND TO HAVE AN INFECTION IN THE DUODENUM AND A PERFORATION IN THE THIRD PORTION OF THE DUODENUM WHICH REQUIRED SURGERY. AFTER THE SURGERY, THE PATIENT REMAINED IN THE ICU FOR APPROXIMATELY SIX WEEKS AND THEN PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138732 HOBBS MEDICAL TOUCHSOFT COAGULATOR COAGULATOR KNS HOBBS MEDICAL, INC. G1120040

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death