MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 4 MM, 30°, CONNECTOR FOR LIGHT GUIDE ON BOTTOM, AUTOCLAVABLE; RIGID RHINOSCOPE

Model Number	WA96201A
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was sent to an olympus service center for evaluation.Inspection and testing confirmed the reported issue.The objective lens was broken.In addition, there was a dent on the distal edge of the objective window due to collision with other devices, there was debris under the eyepiece window due to lens damage, the image was dark and blurry due to damage to the lens, and there were minor scratches on the outer tube due to collision with other devices.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
The customer reported that, during preparation for an unspecified diagnostic procedure, there appeared to be a crack in the objective lens.There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide results of the investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.There was no indication that the event was caused by a misuse or that the event was related to design of the device.Repair history was reviewed and no issues were found related to the reported event.Although a definitive root cause of the defects could not be identified, it was determined that the broken lens was likely caused by excessive force during use by the customer.If additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of this device.

• Brand Name: TELESCOPE, 4 MM, 30°, CONNECTOR FOR LIGHT GUIDE ON BOTTOM, AUTOCLAVABLE
• Common Device Name: RIGID RHINOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, . 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: 16327890
• Report Number: 9610773-2023-00444
• Device Sequence Number: 18140725
• Product Code: EOB
• UDI-Device Identifier: 04042761070034
• UDI-Public: 04042761070034
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K944072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023

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: WA96201A
• Device Catalogue Number: WA96201A
• Device Lot Number: 800433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2022
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2021
• 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