MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 0°, HD, QUICK LOCK, AUTOCLAVABLE; WA53000A

Model Number	WA53000A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E2/e3: no information available for the occupation of the initial reporter or whether they are a healthcare professional.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that the subject device had a lens that came off.The issue was identified during the set up / inspection for use.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields: b5, d8, d9, h2, h3, h4, h6, h11 corrected fields: e3 the device was returned to olympus for inspection and the reported failure was confirmed.In addition, the following reportable malfunctions were identified during the device evaluation: failure of lens, pressure marks on the lens, lens displacement and worn-out on the distal end of the light-guide fibers glass.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: lens came off because of the outer tube was damaged by the excessive force and blurry image due to failure of lens and the light-guide fibers glass.The most probable cause of the complaint is cause traced to component failure.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
No additional information received from customer.

• Brand Name: TELESCOPE, 10 MM, 0°, HD, QUICK LOCK, AUTOCLAVABLE
• Common Device Name: WA53000A
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21141432
• Report Number: 9610773-2025-00378
• Device Sequence Number: 9262519
• Product Code: EWY
• UDI-Device Identifier: 04042761052757
• UDI-Public: 04042761052757
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K950076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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: WA53000A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2010
• 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