MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE ¿ULTRA¿, 4 MM, 70°, WITH TROCAR TUBE CONNECTOR; RIGID SCOPE

Model Number	WA4KA470
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned for repair evaluation and the customer¿s reported problem was confirmed.Although no external lens damage was detected, the internal optical lens was found broken.A review of the manufacturing and quality records (dhr) for the affected serial number was reviewed without detecting any non-conformities or deviations regarding the described issue.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.
Event or Problem Description
The biomedical engineer at the user facility reported the lens appears cracked when looking through the ¿ultra¿ rigid telescope.The customer reported problem was found during reprocessing.No death or injury and no impact to patient or other has been reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the definitive root cause of the cracked lens could not be determined.It is possible that the damage was caused by the use of excessive force by the user.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE ¿ULTRA¿, 4 MM, 70°, WITH TROCAR TUBE CONNECTOR
• Common Device Name: RIGID SCOPE
• 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: 17065526
• Report Number: 9610773-2023-01543
• Device Sequence Number: 6104574
• Product Code: HRX
• UDI-Device Identifier: 04042761083027
• UDI-Public: 04042761083027
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K160249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

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: WA4KA470
• Device Catalogue Number: WA4KA470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• 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: 05/08/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2019
• 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