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	Sharp Edges (4013)
Health Effect - Clinical Codes	Disseminated Intravascular Coagulation (DIC) (1813); Unspecified Infection (1930); Perforation (2001); Pleural Effusion (2010); Sepsis (2067); Unspecified Kidney or Urinary Problem (4503)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a therapeutic examination of the ureter prior to retrograde intrarenal surgery (rirs)/ureteroscopy with laser lithotripsy for kidney stone, there was a perforation of the ureter while using the rigid ureteroscope.The procedure was abandoned when the ureter was seen to be perforated.A double-j stent was passed.The patient subsequently developed a urinoma and septicemia but refused treatment at the current facility.The patient sought further treatment from an interventional radiologist to drain the urinoma.He went to another hospital and was placed on oxygen and developed disseminated intravascular coagulation (dic) and pleural effusion.He was admitted to the intensive care unit (icu), had four surgeries including a percutaneous nephrostomy.This was informed to the customer by the urologist in that hospital.The customer's urologist visited the patient a couple of times.The opinion of the urologist was that the tip of the olympus semi ridged ureteroscope is sharp, not beveled, and this is dangerous because it can perforate the ureter very easily.The scope has not been used since that incident.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's (lm) investigation.The device was evaluated by olympus, and the reported failure was not confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, there were no reportable device abnormalities observed; therefore, the reported failure was not confirmed and the root cause could not be determined.This supplemental report includes an update to d9 and h3 from the initial medwatch.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, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20293390
• Report Number: 9610773-2024-02322
• Device Sequence Number: 12761390
• Product Code: FGB
• UDI-Device Identifier: 04042761029537
• UDI-Public: 04042761029537
• Combination Product (Y/N): N
• Initial Reporter Country: NI
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA02943A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/31/2024
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male