MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "IR", 10 MM, 0°; AUTOCLAVABLE RIGID TELESCOPE

Model Number	WAIR100A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus (omsc) was informed the customer ir, autoclavable rigid telescope was returned to the olympus repair center for a reported ¿objective lens is down¿.The customer reported event was found at an unspecified event.No death or injury and no impact to patient or other has been reported to olympus.Upon inspecting, the misalignment of the objective lens at the distal end of the scope attributing to a cropped image.This report is being submitted to capture the misalignment of the objective lens.
Additional Manufacturer Narrative
The repair inspection confirmed the customer reported issue, the objective lens at the distal end of the scope is misaligned attributing to a cropped image.The legal manufacturer (oste) performed a review of the device history records for the concerned device.There were no nonconformities associated with the device with respect to the described issue.The investigation is still ongoing; therefore, the customer¿s reported issue cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation (h6/h10) and to correct d5.Based on the results of the investigation, the root cause could not be determined.It is likely the reported event occurred due to the use of excessive force from improper handling.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE "IR", 10 MM, 0°
• Common Device Name: AUTOCLAVABLE RIGID TELESCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16231400
• Report Number: 9610773-2023-00323
• Device Sequence Number: 15166668
• Product Code: GCJ
• UDI-Device Identifier: 04042761083621
• UDI-Public: 04042761083621
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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: WAIR100A
• Device Catalogue Number: WAIR100A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2017
• 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