Olympus WA4KL545Recalls & reported problems
OLYMPUS Winter & Ibe GmbH · Telescope "ULTRA", 5.4 mm, 45° · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04042761082891), received between Dec 8, 2022 and Jul 22, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
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
- Break3
- Detachment of Device or Device Component1
- Material Twisted/Bent1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE EVENT OCCURRED DURING POSTOPERATIVE DEVICE REMOVAL AFTER THERAPEUTIC UNSPECIFIED PROCEDURE THAT WAS COMPLETED WITH THE SAME DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19789636 ↗MalfunctionMar 20, 2023Break; Mechanical Problem; Break; Mechanical Problem
THE INTENDED PROCEDURE WAS A LAPAROSCOPY (LAP) PROCEDURE AND THE PROCEDURE WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16572360 ↗MalfunctionJan 18, 2023Break; Break
OLYMPUS (OMSC) REPORTED THE ULTRA, AUTOCLAVABLE RIGID TELESCOPE HAS DAMAGED LENS. THE CUSTOMER REPORTED PROBLEM WAS FOUND AT AN UNSPECIFIED EVENT. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED TO OLYMPUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16200472 ↗MalfunctionDec 8, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent
THE OLYMPUS SALES REPRESENTATIVE WAS INFORMED THAT THE CUSTOMER ULTRA RIGID TELESCOPE HAS A ¿BENT SHAFT AND DAMAGED LENS¿. THE REPORTED PROBLEM WAS FOUND AT REPROCESSING. NO DEATH, INJURY OR HARM WAS REPORTED TO OLYMPUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15942377 ↗
Other Laparoscope, Gynecologic (And Accessories) devices
- Olympus WA50042AOLYMPUS Winter & Ibe GmbH · Laparoscope, Gynecologic (And Accessories)1 recall6,135 reports
- Olympus WA50052AOLYMPUS Winter & Ibe GmbH · Laparoscope, Gynecologic (And Accessories)2,249 reports
- ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-5Olympus Medical Systems Corp. · LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)1 recall1,279 reports
- Olympus WA50040AOLYMPUS Winter & Ibe GmbH · Laparoscope, Gynecologic (And Accessories)1 recall954 reports
- Olympus WA50050AOLYMPUS Winter & Ibe GmbH · Laparoscope, Gynecologic (And Accessories)895 reports
- 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
- HD EndoEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VHOlympus Medical Systems Corp. · LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)168 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.