MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE 7.3/10.4 FR. X 430 MM, 5°, ANGLED OCULAR, 6.4 FR. CHANNEL

Model Number	WA2UR14A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation was confirmed.In addition to the plan glass at distal end was damaged, additional findings were as follows: the outer tube was kinked; particles were found under the cover glass; chipping on the outside of the cover glass.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 customer reported to olympus that the ureteroscope 7.3/10.4 fr.X 430 mm, 5°, angled ocular, 6.4 fr.Channel optics fogged.There was no patient harm associated with the event.The device was evaluated, and it was found that the plan glass at distal end was damaged.This mdr (medical device report) is being submitted to capture the reportable malfunction found during the device evaluation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Updated fields: h6 and h10.The g2 field was corrected based on information available at the time of the initial submission.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 3 years since the subject device was manufactured.Based on the results of the investigation, the damage to the glass occurred due to excessive use by the user.Olympus will continue to monitor field performance for this device.

• Brand Name: URETEROSCOPE 7.3/10.4 FR. X 430 MM, 5°, ANGLED OCULAR, 6.4 FR. CHANNEL
• Common Device Name: URETEROSCOPE
• 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: 17697697
• Report Number: 9610773-2023-02482
• Device Sequence Number: 17989501
• Product Code: FGB
• UDI-Device Identifier: 04042761086363
• UDI-Public: 04042761086363
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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: WA2UR14A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2023
• 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: 08/18/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2020
• 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