Optitherm 20432030Recalls & reported problems
Karl Storz GmbH & Co. KG · Optitherm® Heating Element · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551068663), received between Oct 15, 2021 and Oct 6, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Temperature Problem” (2 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Temperature Problem2
- Excessive Heating1
- Overheating of Device1
Patient problems
- Burn(s)3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 6, 2023Temperature Problem; Excessive Heating; Temperature Problem; Excessive Heating
IT WAS REPORTED THAT DURING A SURGERY, THE HEATING ELEMENT (OPTITHERM 20432030) BURNED THE PATIENT'S SKIN. THE HEATING ELEMENT WAS CONNECTED TO THE THERMOFLATOR AND PROBABLY OVERHEATED.
Patient problems: Burn(s)
MAUDE report 17887261 ↗InjuryOct 6, 2023Temperature Problem; Temperature Problem
IT WAS REPORTED THAT DURING A SURGERY, THE HEATING ELEMENT (OPTITHERM 20432030) BURNED THE PATIENT'S SKIN. THE HEATING ELEMENT WAS CONNECTED TO THE THERMOFLATOR AND PROBABLY OVERHEATED.
Patient problems: Burn(s)
MAUDE report 17886674 ↗InjuryOct 15, 2021Overheating of Device; Overheating of Device
AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): THE "OPTITHERM" ACCESSORY, WHICH WAS INTENDED FOR PREHEATING THE GAS TO BE INSUFFLATED HAS OVERHEATED FAR BEYOND THE INTENDED ALARM LIMIT VALUE OF 41 °C. THIS SITUATION WAS NOT DETECTED BY THE MAIN UNIT. THIS CIRCUMSTANCE WAS NOT DETECTED BY THE MAIN UNIT, SO NO ALARM WAS TRIGGERED. DUE TO THE DIRECT SKIN CONTACT, A LARGE BURN CORRESPONDING TO THE SIZE OF THE HOUSING BURN OCCURRED. TWO DEVICES WERE INVOLVED (OPTITHERM AND THERMOFLATOR). THIS REPORT IS FOR DEVICE 1 (OPTITHERM). (MFR'S. INTERNAL COMPLAINT (B)(4)).
Patient problems: Burn(s)
MAUDE report 12642687 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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