MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE; RIGID URETEROSCOPE

Model Number WA2UR22A

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2022

Event Type  malfunction  

Event Description

Olympus was informed by the operating room manager at the user facility that the customer oes elite, straight ocular dual channel rigid ureteroscope has ¿cracked lens¿.The customer reported problem was found at reprocessing.No death or injury and no impact to person or other was reported to olympus.

Manufacturer Narrative

The referenced scope was returned to the olympus repair center.The repair inspection was unable to confirm the customer¿s reported issue, no cracked lens was observed.However, the inspection noted the image has a darkened area, the rigid outer tube is bent, and debris particles found under the objective window at the distal end of the scope.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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation (h6/h10).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 could not be determined as the reportable malfunction, cracked lens, was not confirmed.Olympus will continue to monitor field performance for this device.

• Brand Name: URETEROSCOPE
• Type of Device: RIGID 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: 16151510
• MDR Text Key: 307599474
• Report Number: 9610773-2023-00203
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04042761086424
• UDI-Public: 04042761086424
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2023

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
• Device Operator: Health Professional
• Device Model Number: WA2UR22A
• Device Catalogue Number: WA2UR22A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1