MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "IR", 5.4 MM, 0°; AUTOCLAVABLE RIGID TELESCOPE

Model Number	WAIR500A
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus was informed by the instrument specialist at the user facility, the autoclavable rigid telescope ¿light post was disconnected from the scope at the end of the procedure/nurse manager broken off light post from scope¿.The reported problem was found during reprocessing.No death or injury and no impact to patient or other has been reported to olympus.
Additional Manufacturer Narrative
(b)(4) : oste investigation results: since the product for this info complaint was not returned to oste, our investigation is based solely on the information provided by the customer.The product was sold on: 08 sep 2021.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation (h6/h10).The device was returned to olympus for inspection, and the customer's complaint was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.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.In addition, the following non-reportable malfunctions were found during the device evaluation; scratches on the outer tube, distal fiber breakage, scratches on the eyepiece funnel, and a broken lens in the optical system.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE "IR", 5.4 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: 16394998
• Report Number: 9610773-2023-00529
• Device Sequence Number: 20441310
• Product Code: GCJ
• UDI-Device Identifier: 04042761086172
• UDI-Public: 04042761086172
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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: WAIR500A
• Device Catalogue Number: WAIR500A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2021
• 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