MAUDE Adverse Event Report: Olympus Winter & Ibe GmbH Video telescope "ENDOEYE HD II", 5.4 mm, 0°, autoclavable; rigid video laparoscope

Model Number	WA50050A
Medical Device Problem Codes	No Display/Image (1183); Communication or Transmission Problem (2896); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction

• Brand Name: Video telescope "ENDOEYE HD II", 5.4 mm, 0°, 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 ; +1(508)207-7661
• MDR Report Key: 50765976
• Report Number: 9610773-2026-06168
• Device Sequence Number: 9224419
• Product Code: HET
• UDI-Device Identifier: 04042761075008
• UDI-Public: 04042761075008
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K190744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: WA50050A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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