n.a. 27050VLRecalls & reported problems
Karl Storz GmbH & Co. KG · LASER Working Insert, · 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 04048551232965), received between Jan 8, 2025 and Jan 8, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Detachment of Device or Device Component1
- Device Handling Problem1
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.
MalfunctionJan 8, 2025Break; Detachment of Device or Device Component; Device Handling Problem; Break; Detachment of Device or Device Component; Device Handling Problem
IT WAS REPORTED THAT A RESECTOSCOPE HAS BEING USED WITH GREEN LIGHT LASER VIA COMPATIBLE LASER WORKING INSERT 27050VL. THE SURGEON FIRED LASER WHILE INSIDE THE SHEATH RESULTING IN THE INNER SHEATH BREAKING OFF - THE CERAMIC BEAK BROKE OFF INSIDE. THE VISIBLE BROKEN PARTS WERE RETRIEVED. THE REMAINING BROKEN PARTS WERE EXPELLED VIA IRRIGATION. THE SURGEON AND TEAM WERE SATISFIED AS THERE WERE NO REMAINING PARTS IN PATIENT.THE SURGERY WAS PROLONGUED FOR LESS THAN 15 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFEREBCE MDR: 9610617-2025-00005.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21103845 ↗
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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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