MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE, 7,5 FR. X 430 MM, 7°, 2 CHANNELS, OCULAR ANGLE 45°; RIGID URETEROSCOPE

Model Number	WA02943A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to the olympus repair center.The repair inspection confirmed the customer¿s reported issue, the lens is damaged attributing to a poor/blurry image.The investigation is still ongoing; therefore, the customer¿s reported issue cannot be determined at this time.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
Olympus (oaz) was informed that the customer ultra, rigid autoclavable telescope has ¿cracked lens¿.The customer reported issue was found during inspection before use.No death or injury and no impact to patient or other has been reported to olympus.
Event or Problem Description
Additional information was provided.The nurse dropped the device and damaged the lens.The intended procedure was a therapeutic transurethral lithotripsy (tul) surgery.There was no delay to the procedure and the surgery was completed using a different scope.It was further noted that the scope is used two to three times a month.
Additional Manufacturer Narrative
Updated fields: h6, h10 corrected fields: b5 (information was inadvertently omitted from the initial), d5 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.Based on the results of the investigation, the root cause could not be determined.The reported event occurred due to use error/improper handling as the device was reported to have been dropped.The impact from the drop resulted in a damaged lens.Olympus will continue to monitor field performance for this device.

• Brand Name: URETEROSCOPE, 7,5 FR. X 430 MM, 7°, 2 CHANNELS, OCULAR ANGLE 45°
• Common Device Name: 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: 16231363
• Report Number: 9610773-2023-00322
• Device Sequence Number: 12510913
• Product Code: FGB
• UDI-Device Identifier: 04042761029537
• UDI-Public: 04042761029537
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951855
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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: WA02943A
• Device Catalogue Number: WA02943A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2014
• 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