n.a. 27040EORecalls & reported problems
Karl Storz GmbH & Co. KG · Working Element, bipolar · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048551323243), received between Apr 23, 2026 and Apr 23, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Optical Obstruction” (1 report).
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
- Optical Obstruction1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2026Optical Obstruction
IT WAS REPORTED THAT, FOLLOWING A DISCUSSION WITH THE OPERATING ROOM TEAM, THE RESECTOSCOPE WAS NOT USED DUE TO A VISION ISSUE. SPECIFICALLY, THE FOLLOWING ASSEMBLY: 30° OPTIC, REF. 27325 BA, RESECTION HANDLE, REF. 27040E0, SHEATH, REF. 27051XA, IRRIGATION SHEATH, REF. 27051PL. DOES NOT ALLOW THE OPTIC TO BE FLUSH WITH THE EDGE OF THE SHEATH, RESULTING IN A TRUNCATED IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24967481 ↗
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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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