MAUDE Adverse Event Report: HOBBS MEDICAL, INC. TOUCHSOFT COAGULATOR; ENDOSCOPIC MONOPOLAR ELECTROSURGICAL COAGULATOR

Model Number	G11-200-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	12/17/2024
Type of Reportable Event	Death
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: TOUCHSOFT COAGULATOR
• Common Device Name: ENDOSCOPIC MONOPOLAR ELECTROSURGICAL COAGULATOR
• Manufacturer (Section D): HOBBS MEDICAL, INC.; 8 spring street; stafford springs CT 06076
• Manufacturer (Section G): HOBBS MEDICAL, INC.; 8 spring street; stafford springs CT 06076
• Manufacturer Contact: jennifer hodge ; 8 spring street; stafford springs, CT 06076 ; 8606845875
• MDR Report Key: 21517346
• Report Number: 1220592-2025-00001
• Device Sequence Number: 9712656
• Product Code: KNS
• UDI-Device Identifier: M849G11200400
• UDI-Public: M849G11200400
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K093079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: G11-200-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ERBE ELECTROSURGICAL GENERATOR
• Outcome Attributed to Adverse Event: Life Threatening; Death; Required Intervention; Hospitalization
• Patient Sex: Unknown