NA 26606ACARecalls & reported problems
Karl Storz GmbH & Co. KG · TIPCAM1 RUBINA 0°, OPAL1 NIR/ICG, 4K 3D · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551425671), received between May 25, 2025 and Sep 29, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (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. 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
- Defective Component1
- Optical Problem1
- Temperature Problem1
Patient problems
- Burn(s)1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Temperature Problem
It was reported that the staff member wore two pairs of gloves throughout the procedure. Thirty minutes after the procedure, she experienced pain. They discovered a burn covering the entire surface of the left hand that was in contact with the device.
Patient problems: Burn(s)
MAUDE report 50941329 ↗MalfunctionMay 25, 2025Defective Component; Optical Problem; Defective Component; Optical Problem
IT WAS REPORTED THAT "IT HAS STOPPED WORKING AFTER A SHORT TIME OF USE AND DOUBTS THE QUALITY". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22082516 ↗
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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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