LAZIC 70.581.01Recalls & reported problems
Peter Lazic GmbH · CUSHING-LANGOLT SPECULA , 70 x 15MM FOR TRANS-SPHENOIDALE HYPOPHYSECTOMY BLACK COATED · Class 1
Data updated Oct 16, 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 04250603738718), received between Dec 19, 2023 and Dec 19, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (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
- Mechanical 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.
MalfunctionDec 19, 2023Mechanical Problem; Mechanical Problem
THE INCIDENT HAPPENED ON (B)(6) 2023. FEEDBACK THAT THE INCIDENT OCCURRED WAS RECEIVED BY PETER LAZIC GMBH ON (B)(6) 2023. THE INCIDENT HAPPENED IN A HOSPITAL IN GERMANY. THE HOSPITAL STATES THAT THE SPECULUM WAS INSERTED INTO THE RIGHT SIDE OF THE NOSE AND SPREAD OPEN. AFTER COMPLETION OF THE PROCEDURE, THE SPREADER COULD NOT BE TWISTED BACK TOGETHER, SO IT HAD TO BE REMOVED IN A WIDE OPEN STATE. THE HOSPITAL STATES THAT IT COULD HAVE LED TO A SERIOUS DETERIORATION OF THE PATIENT'S HEALTH. THE INVESTIGATION OF THE CAUSE IS ON-GOING. NO PATIENT DATA OR FURTHER DATA ON THE PROCEDURE ARE KNOWN. INTERNAL IDENTIFICATION NUMBER (B)(4) .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18353295 ↗
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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