MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE WITH WA00395A; AUTOCLAVABLE URETEROSCOPE

Model Number	WA29049A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus was informed that the customer straight ocular angle autoclavable ureteroscope has a broken off component defect, ¿the light post is missing¿.The customer reported event was found at an unknown event.No death or injury and no impact to patient or other has been reported to olympus.
Additional Manufacturer Narrative
Olympus followed up with the customer to obtain the serial number of the scope, but no information was obtained.The referenced device was returned to the olympus repair center, but the evaluation has not yet begun.Also, 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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Additionally, as no serial number was provided the manufacturing date is unavailable.Based on the available information, the root cause could not be determined.It is likely the reported event occurred due to the use of excessive force by the customer.Olympus will continue to monitor field performance for this device.

• Brand Name: URETEROSCOPE WITH WA00395A
• Common Device Name: AUTOCLAVABLE URETEROSCOPE
• 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: 16276092
• Report Number: 9610773-2023-00396
• Device Sequence Number: 7057979
• Product Code: FGB
• UDI-Device Identifier: 04042761063043
• UDI-Public: 04042761063043
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K951855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2023

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: WA29049A
• Device Catalogue Number: WA29049A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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