MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE

Model Number OLYMPUS URF-V2R

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

Patient Problems Sepsis (2067); Unspecified Kidney or Urinary Problem (4503)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus.Therefore, the exact cause of the reported event could not be conclusively determined.Since the lot number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there was no description of the device's malfunction.

Event Description

On december 22, olympus medical systems corp.(omsc) received the literature "original article: clinical investigation comparison of the safety and efficacy between the prone split-leg and galdakao-modified supine valdivia positions during endoscopic combined intrarenal surgery: a multi-institutional analysis¿.The purpose of the literature was to evaluate the safety and efficacy of the prone split-leg and the galdakao-modified supine valdivia (gmsv) positions during endoscopic combined intrarenal surgery.The procedure was performed using an endoscope (urf-v2, or urf-p6).The other devices were manufactured by non-olympus.In the literature, it was reported 7 cases of sepsis, 1 case of thoracic complication, 38 cases of febrile urinal tract infection (futi), 15 cases of urinary tract injury around the ureteropelvic junction (upj), and 3 cases of transfusion.There was no more information about 7 cases of sepsis, 1 case of thoracic complication, 38 cases of futi.1 of 15 urinary tract injuries around the upj was grade 3.¿the incidence of blood transfusion was 0.8% and 2.0% in the prone split-leg (psl) and gmsv positions, respectively.The incidence of blood transfusion in this study was low compared to that of previous report of percutaneous nephrolithotomy (pcnl) in each position.This could be attributable to use of the mini-pcnl tract, renal puncture by ultrasonography, and use of flexible ureteroscopy that reduces excessive movement of the pcnl tract for inaccessible calculi.¿ on december 23, medical safety officer, who has the medical license, reviewed that futi is decided as not serious injury.Based on the available information, no malfunction was reported and a direct relationship between the olympus product and these complications could not be determined.However, 7 cases of sepsis, 1 case of grade urinary tract injuries around the upj, and 3 cases of transfusion might be serious injury, and the olympus endoscope might be associated with these complications.This is the report regarding 7 cases of sepsis, 1 case of grade urinary tract injuries around the upj, and 3 cases of transfusion.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13091117
• MDR Text Key: 288290169
• Report Number: 8010047-2021-16895
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343612
• UDI-Public: 04953170343612
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2021

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 Model Number: OLYMPUS URF-V2R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 12/27/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other