MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE; OES ELITE URETEROSCOPES

Model Number	WA2UR21A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that when using a ureteroscope 6.9/8.4 fr.X 430 mm, it broke in the insertion tube and the user lost the image.The event occurred during the therapeutic procedure (uteroscopy) was completed with a similar device.There was no patient harm associated with the event.
Additional Manufacturer Narrative
D1 - brand name - ureteroscope 6.9/8.4 fr.X 430 mm, 5°, angled ocular, 3.7 fr.And 2.6 fr.Channel.The device was returned and evaluated, and the customer¿s allegation (broken insertion tube) was not confirmed.However, the insertion tube was bent, there was a deep dent on the distal edge and debris under the cover glass, and there was no image.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
The procedure, a laser ureteroscopy, was for a stone rupture.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information provided by the customer (b5/event description).
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.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, it is likely that the reported issue was due to excessive use.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿a suitable replacement device must be provided during an application.¿ olympus will continue to monitor field performance for this device.

• Brand Name: URETEROSCOPE
• Common Device Name: OES ELITE URETEROSCOPES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, 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: 17814526
• Report Number: 9610773-2023-02705
• Device Sequence Number: 6205300
• Product Code: FGB
• UDI-Device Identifier: 04042761086417
• UDI-Public: 04042761086417
• Combination Product (Y/N): N
• PMA/510(K) Number: K200369
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2024

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: WA2UR21A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/12/2023; 12/20/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/16/2023; 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2022
• 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