MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VIDEO TELESCOPE "ENDOEYE", 5 MM, 0°, NTSC, AUTOCLAVABLE; RIGID VIDEO LAPAROSCOPE

Model Number	WA50021B
Medical Device Problem Codes	Break (1069); Poor Quality Image (1408); Dent in Material (2526); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection.A root cause could not be identified.Based on the results of the investigation, the most probable cause of the distal fiber breakage and the dents and scratches on the objective frame at the distal end was traced to component failure.In addition, the cause of the image being out of field was determined to be a bent outer tube.The date of event is unknown.Additional information will be provided if available.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer returned the rigid video laparoscope to the service center for a separate issue.During the device analysis, the service repair technician identified that the device exhibited distal fiber breakage, dents and scratches on the objective frame at the distal end, and an image that was out of field.There was no patient involvement.

• Brand Name: VIDEO TELESCOPE "ENDOEYE", 5 MM, 0°, NTSC, AUTOCLAVABLE
• Common Device Name: RIGID VIDEO LAPAROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 25448456
• Report Number: 9610773-2026-04353
• Device Sequence Number: 14893958
• Product Code: HET
• UDI-Device Identifier: 04042761066815
• UDI-Public: 04042761066815
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K955456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: WA50021B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown