MAUDE Adverse Event Report: Olympus Winter & Ibe GmbH Video telescope "ENDOEYE HD II", 10 mm, 30°, autoclavable; Laparoscope, Gynecologic

Model Number	WA50042A
Medical Device Problem Codes	Break (1069); Erratic or Intermittent Display (1182); Electrical /Electronic Property Problem (1198); Fracture (1260); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the olympus gynecologic laparoscope had an error e226 during an unspecified procedure.During the initial evaluation of the device it was observed, the fiber bonding in the outer tube area is damaged, the charged coupled device is broken, the dielectric strength is inadequate and stripes in image occur were observed.No patient harm was reported.
Additional Manufacturer Narrative
The device was returned to olympus for inspection and the reported failure was not confirmed.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: error code e226 was not detected and the fiber bonding in the outer tube area is damaged, the charged coupled device is broken, the dielectric strength is inadequate and stripes in image occur, cause traced to component failure.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.

• Brand Name: Video telescope "ENDOEYE HD II", 10 mm, 30°, autoclavable
• Common Device Name: Laparoscope, Gynecologic
• 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 ; +1(508)207-7661
• MDR Report Key: 50917926
• Report Number: 9610773-2026-06408
• Device Sequence Number: 12207069
• Product Code: HET
• UDI-Device Identifier: 04042761074971
• UDI-Public: 04042761074971
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K190744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: Health Professional
• Device Model Number: WA50042A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown