MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE, 6,4/7,8 FR. X 430 MM, 7°, 4,2 FR. CHANNEL, WITH WA00395A; ULTRATHIN URETEROSCOPES

Model Number	WA29040A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Urinary Tract Infection (2120)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the literature described ¿urf-v2r, urf-v3, urf-v2¿, olympus selected ¿urf-v2r¿ as a representative product.The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.*the literature article is attached for additional information.
Event or Problem Description
Olympus reviewed the following literature titled "quality of life after urinary stone surgery based on japanese wisconsin stone quality of life questionnaire: multicenter analysis from smart study group." we aimed to evaluate the impact of surgical treatment for urinary stones on perioperative health-related quality of life (hrqol) using the japanese wisconsin stone quality of life questionnaire (j-wisqol), an hrqol measure designed for patients with urinary stones.This study prospectively enrolled 123 patients with urinary stones who visited three academic hospitals for stone treatment.The participants completed the j-wisqol within 4 weeks before and after the urinary stone treatment.Treatments included shock wave lithotripsy (swl), ureteroscopy lithotripsy, and endoscopic combined intrarenal surgery.J-wisqol was assessed for age, stone size and location, type of treatment, stone-free status, postoperative ureteral stent placement, hospital stay, and complications in all patients.Patients with stones in the ureter had significantly greater social impact d1 and disease impact d3 than those with stones in the kidney.In a comparison of pre- and postoperative j-wisqol, patients without postoperative ureteral stent placement scored significantly higher on social impact d1 and disease impact d3.Patients with shorter hospital stays had significantly higher social impact d1 and disease impact d3 (p < 0.001) than those with longer hospital stays.Swl significantly improved the total score, social impact d1, and disease impact d3 compared with other treatments.Perioperative hrqol in patients with urinary stones is particularly affected by the type of treatment, ureteral stent placement, and hospital stay, which should be considered in surgical selection and patient decision-making.Type of adverse events/number of patients: perioperative complications (fever and urinary tract infection)- 6 patients.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6) /urf-v2r.(b)(6) /wa29040a.The medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: URETEROSCOPE, 6,4/7,8 FR. X 430 MM, 7°, 4,2 FR. CHANNEL, WITH WA00395A
• Common Device Name: ULTRATHIN 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: 18165542
• Report Number: 9610773-2023-03331
• Device Sequence Number: 12574446
• Product Code: FGB
• UDI-Device Identifier: 04042761062497
• UDI-Public: 04042761062497
• 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,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: WA29040A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown