Olympus A64070ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Jaws "HiQ+", 5 x 330 mm, alligator type · 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 04042761010115), received between Oct 24, 2023 and Oct 24, 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. How this data works · Data updated Oct 13, 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.
MalfunctionOct 24, 2023Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED TO OLYMPUS THAT THE JAWS ALLIGATOR TYPE HIQ HAD THE JAWS FITTING GAP WORN OUT AS IT WAS TOO WIDE. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17999718 ↗
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- ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-5Olympus Medical Systems Corp. · Laparoscope, Gynecologic (And Accessories)624 reports
- Epix Laparoscopic Scissors CB030Applied Medical Resources Corporation · Laparoscope, Gynecologic (And Accessories)239 reports
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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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