MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. URETERO-RENO FIBERSCOPE

Model Number URF-P6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Urethral Stenosis/Stricture (4501); Unspecified Kidney or Urinary Problem (4503)

Event Date 09/21/2021

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled "the impact of preoperative percutaneous nephrostomy as a treatment strategy before flexible ureteroscopy for impacted upper ureteral stones with hydronephrosis".Literature summary: the current study aimed to evaluate the impact of preoperative percutaneous nephrostomy (pns) as a treatment strategy before flexible ureteroscopy (f-urs) of asymptomatic impacted upper ureteral stones with hydronephrosis.There were no significant differences in age, sex, and stone size between the two groups except in the grade of hydronephrosis, with group a having more cases of advanced hydronephrosis than group b.The stone-free rate was significantly higher in group a than in group b.However, there were no significant differences between the groups in operation time, postoperative fever, and postoperative hospital days.In group a, preoperative pns placement was performed 4 days before f-urs, and the pns was removed postoperatively on the same day of the f-urs.Additionally, subgroup analysis was performed in cases of grade 2 and 3 hydronephrosis.A total of 110 patients, 60 who underwent f-urs with pns and 50 who underwent f-urs without pns, were included.The stone-free rate was significantly higher in f-urs with pns than in f-urs without pns.However, no significant differences were found between the groups in operation time, ureteral injury, postoperative fever, and postoperative hospital days.Type of adverse events/number of patients: urs with pns (n=61): uretral injury - 3 patients, fever - 3 patients, postoperative hydronephrosis -10 patients.Urs without pns (n=75): uretral injury - 8 patients, fever - 4 patients, postoperative hydronephrosis - 12 patients, ureteral stenosis - 2 patients.This complaint is (b)(6).

Manufacturer Narrative

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.

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: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15117633
• MDR Text Key: 296759641
• Report Number: 9610595-2022-00362
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340802
• UDI-Public: 04953170340802
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

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
• Device Operator: Health Professional
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 07/27/2022
• Supplement Dates Manufacturer Received: 09/05/2022
• Supplement Dates FDA Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other