Hobbs Medical TouchSoft Coagulator G1120040Recalls & reported problems
Hobbs Medical, Inc. · An assembly of devices that uses radio-frequency (RF) alternating current to develop heat directly within soft-tissue cells (thermodynamic) for cutting and coagulating tissue within a shield of argon (Ar) gas during surgery. It typically includes a generator, a single-use/reusable electrode handpiece with monopolar electrodes, connecting cables, foot-switch, and an argon gas supply system [housed in a separate trolley (cart) or incorporated into the system generator]. The current forms an ionized channel or arc within the argon shield which lessens the charring of tissue and provides rapid, uniform coagulation over large bleeding surfaces (e.g., capillary beds). · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M849G11200400), received between Mar 4, 2025 and Mar 4, 2025 — classified as 1 death.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bowel Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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. TOUC
Patient problems: Bowel Perforation
MAUDE report 21517346 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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