n.a. 8606FRecalls & reported problems
Karl Storz GmbH & Co. KG · Coagulation Suction Tube, 3.5 mm · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04048551213698), received between Jun 29, 2023 and Jul 22, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Naturally Worn2
Patient problems
- Burn(s)2
- Superficial (First Degree) Burn2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE INSULATION ON THE INSTRUMENT WAS DAMAGED AND CAUSED A BURN ON A PATIENT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Superficial (First Degree) Burn
MAUDE report 19801271 ↗InjuryJul 22, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE INSULATION ON THE INSTRUMENT WAS DAMAGED AND CAUSED A BURN ON A PATIENT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Superficial (First Degree) Burn
MAUDE report 19798072 ↗InjuryJun 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THERE WAS A CUT IN THE SHAFT OF THE INSULATED HAND PIECE. SPIKE FROM THE EXPOSED METAL BURNED THE PATIENT'S LIP.
Patient problems: Burn(s)
MAUDE report 17232655 ↗InjuryJun 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
CUT IN THE SHAFT OF THE INSULATED HAND PIECE. SPIKE FROM THE EXPOSED METAL BURNED THE PATIENT'S LIP.
Patient problems: Burn(s)
MAUDE report 17232258 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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