MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. URETERO-RENO VIDEOSCOPE

Model Number URF-V

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

Patient Problems Hematoma (1884); Sepsis (2067); Unspecified Heart Problem (4454); Unspecified Gastrointestinal Problem (4491); Unspecified Kidney or Urinary Problem (4503)

Event Date 02/10/2022

Event Type  Injury  

Event Description

Olympus reviewed the following literature: investigation of risk factors for postoperative febrile urinary tract infection in transurethral nephroureteral lithotripsy-retrospective analysis of 1,235 single-center cases.Literature summary] in recent years, transurethral uretcrolithotripsy (tul) has made great strides and is now widely used, including improvements in ureteroscopes, laser lithotripsy devices, peripheral devices, and standardization of surgical procedures.Tul is often selected for renal lithotripsy of 20 mm or larger because it is more efficient than extracorporeal impact wave lithotripsy and less invasive than percutaneous renal lithotripsy.The frequency of tul complications cited is 9-25%, but most are reported by tul (rigid tul: r-tul) using only a rigid ureteroscope.Although there are some reports of treatment results of tul (flexible tul: f-tul) using urethra, the number of cases reported from a single institution is limited.Inconsistent surgical procedures may affect the analysis results.We have been performing f-tul since 2012 and have experienced more than 1,000 cases to date.Tul the most common postoperative complication is febrile urinary tract infection (futi), which can sometimes have serious outcomes.The course of treatment was analyzed to examine the incidence of futi after tul and its risk factors.Postoperative complications and retreatment are shown in table 4: the futi was 127 (10.3%), and 18 (1.5%) had internal sepsis.Most of the cases were grade 2, but septic shock due to (grade 4) futi, which required strict icu management such as vasopressors, was observed in 5 cases (0.4%).In addition, urinary retention was observed in 8 cases (0.6%), of which 5 cases (0.4%) were due to bladder tamponade.There were 6 cases (0.5%) of subcapsular hematoma and 10 cases (0.8%) of cardiovascular events and cd enteritis.[type of adverse events / number of patients] furf, sepsis, subcapsular hematoma, urinary retention , bladder tamponade, the others (cardiovascular events, crohn's disease enteritis and etc).

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.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 VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15216744
• MDR Text Key: 297860351
• Report Number: 3002808148-2022-00913
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 4953170340321
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072957
• 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: 10/12/2022

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-V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 08/12/2022
• Supplement Dates Manufacturer Received: 09/20/2022
• Supplement Dates FDA Received: 10/12/2022
• 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
• Treatment: NON-OLYMPUS URETERAL STENTS.
• Patient Outcome(s): Required Intervention; Other