MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH CYSTOSCOPE, 30°, 17 FR. X 225 MM, 9 FR. CHANNEL, OCULAR ANGLE 45°; OCULAR ANGLE RIGID CYSTOSCOPE

Model Number	A20919A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The repair inspection confirmed the customer¿s reported problem, the image is blurry/cloudy due to broken internal lens.Also, during the service inspection, the stopcock fixing screw was found missing (reportable defect).Other defects noted were deformation of the rigid outer tube, deep scratches on the outer tube, and debris particles in the whole device.The cause of the stopcock fixing screw dropout is unknown.However, the investigation is still in progress.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.
Event or Problem Description
Olympus (omsc) was informed that the customer single channel, ocular angle rigid cystoscope was returned to the olympus service center for a reported ¿cloudy lens¿ which was found at an unspecified event.During the service inspection, the stopcock fixing screw was found missing.No death or injury and no impact to patient or other was reported to olympus.This report is being submitted to capture the broken, missing component.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 of the observed missing stopcock fixing screw and broken internal lens were found to likely be the result of user error, improper handling and application of excessive force.Olympus will continue to monitor field performance for this device.

• Brand Name: CYSTOSCOPE, 30°, 17 FR. X 225 MM, 9 FR. CHANNEL, OCULAR ANGLE 45°
• Common Device Name: OCULAR ANGLE RIGID CYSTOSCOPE
• 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: 16199989
• Report Number: 9610773-2023-00264
• Device Sequence Number: 14534721
• Product Code: GCP
• UDI-Device Identifier: 04042761030052
• UDI-Public: 04042761030052
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K790071
• 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): 04/27/2023

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: Other
• Device Model Number: A20919A
• Device Catalogue Number: A20919A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2007
• 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