MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 45°, HD, QUICK LOCK, AUTOCLAVABLE; AUTOCLAVABLE RIGID TELESCOPE

Model Number	WA53010A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to the olympus repair center for evaluation and the customer¿s reported problem was confirmed/reproduced as the light guide post was damaged.Additionally, the objective coverglass at the distal end of the scope was found broken.The inspection also observed a dent on the rigid outer tube and the image is blurry or distorted.The investigation is still in progress; 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 501(k): k923982/ k950076.
Event or Problem Description
The customer high definition, quick lock autoclavable rigid telescope was returned to the olympus repair center for a reported ¿the light guide connector part cannot be removed¿.The customer reported event was found at an unspecified event.During the olympus inspection, a broken objective coverglass at the distal end of the scope was found.No death or injury and no impact to patient or other has been reported to olympus.No further details regarding the event have been obtained or provided.This report is being submitted to capture the broken objective lens at the distal end.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to h8.Please see updates to h6, h8, and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 12 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the connector part couldn¿t be removed due to user error, improper handling and application of excessive force.The final root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 10 MM, 45°, HD, QUICK LOCK, AUTOCLAVABLE
• 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: 16563059
• Report Number: 9610773-2023-00777
• Device Sequence Number: 5498343
• Product Code: EWY
• UDI-Device Identifier: 04042761052771
• UDI-Public: 04042761052771
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K912362
• 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): 07/05/2023

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: WA53010A
• Device Catalogue Number: WA53010A
• Device Lot Number: 588602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2011
• 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