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Olympus WA50080ARecalls & reported problems

OLYMPUS Winter & Ibe GmbH · Video telescope ENDOEYE 3D 10 mm, 0° · Class 2

Quick summary

This Olympus ENDOEYE video telescope, a rigid endoscope, has 248 reports on file, with no deaths and 1 injury. Many describe poor or blurry images, and others describe breaks, dents in the outer tube, or no display at all. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
245
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 245 adverse event reports that list this exact device (DI 04042761083485), received between Apr 15, 2024 and Sep 30, 2026 — classified as 1 injury, 244 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (93 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 4 reportsMay 2024: 8 reportsJun 2024: 14 reportsJul 2024: 9 reportsAug 2024: 8 reportsSep 2024: 6 reportsOct 2024: 16 reportsNov 2024: 4 reportsDec 2024: 11 reportsJan 2025: 13 reportsFeb 2025: 7 reportsMar 2025: 5 reportsApr 2025: 3 reportsMay 2025: 7 reportsJun 2025: 7 reportsJul 2025: 4 reportsAug 2025: 3 reportsSep 2025: 1 reportsOct 2025: 6 reportsNov 2025: 11 reportsDec 2025: 27 reportsJan 2026: 7 reportsFeb 2026: 8 reportsMar 2026: 18 reportsApr 2026: 12 reportsMay 2026: 9 reportsJun 2026: 4 reportsJul 2026: 6 reportsAug 2026: 5 reportsSep 2026: 2 reportsOct 2026: 0 reports20242025202627
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Poor Quality Image93
  • Break35
  • No Display/Image24
  • Communication or Transmission Problem23
  • Dent in Material13
  • Display or Visual Feedback Problem12
  • Failure to Clean Adequately11
  • Scratched Material11

Patient problems

  • No Clinical Signs, Symptoms or Conditions244
  • Insufficient Information2

Recent adverse event reports

The 25 most recent of 245 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 30, 2026Failure to Clean Adequately

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50954823 ↗
  • MalfunctionSep 10, 2026Poor Quality Image

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50718535 ↗
  • MalfunctionAug 24, 2026Erratic or Intermittent Display

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50409528 ↗
  • MalfunctionAug 18, 2026Degraded; Material Rupture

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50303426 ↗
  • MalfunctionAug 7, 2026Dent in Material

    The customer returned the rigid video laparoscope, which is an Olympus asset with no reported complaint. During the evaluation of the device, dented outer tube was observed. The repair center technician assessed the condition and determined that the cause of damage was most likely due to component failure. There was no patient involvement.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50180433 ↗
  • MalfunctionAug 5, 2026Poor Quality Image

    The customer reported a blurry image during inspection for use involving an Olympus Rigid Video Laparoscope. There was no patient involvement.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50145515 ↗
  • MalfunctionAug 4, 2026Disconnection; No Display/Image

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50132562 ↗
  • MalfunctionJul 31, 2026Image Display Error/Artifact

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50104266 ↗
  • MalfunctionJul 28, 2026

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50058756 ↗
  • MalfunctionJul 20, 2026Poor Quality Image

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25875592 ↗
  • MalfunctionJul 17, 2026No Display/Image

    THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. HOWEVER, DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN IDENTIFIED THAT THE 2D RIGHT CHANNEL HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25856904 ↗
  • MalfunctionJul 16, 2026No Display/Image; Communication or Transmission Problem

    THE CUSTOMER RETURNED THE RIGID VIDEO SCOPE, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, ERROR CODE (E228) OCCURRED AND THEREFORE NO IMAGE WAS DISPLAYED. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE OF THE FINDING WAS DUE TO COMPONENT FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25839569 ↗
  • MalfunctionJul 8, 2026Moisture Damage

    THE CUSTOMER RETURNED THE RIGID VIDEO LAPAROSCOPE, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, MOISTURE DAMAGED WAS OBSERVED. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE OF THE MOISTURE DAMAGED WAS DUE TO COMPONENT FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25752251 ↗
  • MalfunctionJun 29, 2026Poor Quality Image; Communication or Transmission Problem

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A CONNECTION ERROR AND SHOWED LINES INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WAS NO PATIENT INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25652446 ↗
  • MalfunctionJun 26, 2026Poor Quality Image

    THE CUSTOMER RETURNED THE RIGID VIDEO LAPAROSCOPE, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, BLURRY IMAGE WAS OBSERVED. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE OF THE BLURRY IMAGE WAS DUE TO COMPONENT FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25640733 ↗
  • MalfunctionJun 26, 2026Poor Quality Image

    THE CUSTOMER REPORTED A STATIC IMAGE, A FOUR PART GRAYSCALE IMAGE, AND THE ABSENCE OF A NORMAL IMAGE DISPLAY IN AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WAS NO PATIENT INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25638659 ↗
  • MalfunctionJun 6, 2026Poor Quality Image

    THE CUSTOMER RETURNED THE RIGID VIDEO LAPAROSCOPE, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE IMAGE MISALIGNMENT WAS OBSERVED. THE SERVICE REPAIR TECHNICIAN ASSESSED THE CONDITION AND DETERMINED THAT THE DAMAGE WAS DUE TO A COMPONENT FAILURE OF THE CHARGED COUPLED DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25419237 ↗
  • MalfunctionMay 29, 2026Poor Quality Image

    THE CUSTOMER REPORTED BLURRY IMAGE INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WAS NO PATIENT INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25333580 ↗
  • MalfunctionMay 22, 2026Fracture; Material Split, Cut or Torn

    THE RIGID VIDEO LAPAROSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF NO CUSTOMER ALLEGATION. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, DAMAGED FIBRE BONDING IN THE OUTER TUBE AREA (DISTAL END) AND CUT IN PROTECTOR OF THE VIDEO CABLE SECTION WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25260558 ↗
  • MalfunctionMay 20, 2026Material Split, Cut or Torn; Sharp Edges

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE HAD CONTOUR SHARPNESS AT THE DISTAL END OF THE INSERTION SECTION, AND THE CHARGED COUPLED DEVICE (R-UNIT) WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25233925 ↗
  • MalfunctionMay 11, 2026Scratched Material

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE OBJECTIVE LENS HAS SCRATCHES. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25134393 ↗
  • MalfunctionMay 7, 2026Poor Quality Image

    IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD THREE DIMENSIONAL FUNCTION IS DEFECTIVE. THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORT OF PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25116240 ↗
  • MalfunctionMay 7, 2026Poor Quality Image

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25108843 ↗
  • MalfunctionMay 5, 2026Poor Quality Image

    IT WAS REPORTED THAT DURING A THERAPEUTIC RETROPERITONEAL SUBPERITONEAL NEPHROURETERECTOMY PROCEDURE, THE RIGID VIDEO LAPAROSCOPE DID NOT COME INTO FOCUS EVEN AT THE SPECIFIED FOCAL LENGTH. THE ISSUE OCCURRED DURING SEDATION WHILE THE DEVICE WAS INSIDE THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING AN OLYMPUS BACKUP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25080646 ↗
  • MalfunctionMay 1, 2026Optical Problem

    IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD AN IMAGE DEFECT. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25056142 ↗

Other Endoscope, Rigid devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.