MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES URETERORENOFIBERSCOPE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number URF-P3

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

Patient Problems Bacterial Infection (1735); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

This report is being submitted to report study findings reported in the literature article as well as investigation results.The device(s) referenced in this report have not been returned to olympus for evaluation, therefor physical evaluation of the complaint device(s) could not be performed.The device history record (dhr) for the complaint device could not be reviewed since the serial number was not provided.Olympus does not ship any device that does not meet all design and safety specifications ¿¿ conclusion: since no abnormalities or defects of the subject device(s) were reported, the definitive cause cannot be determined.The study aimed to analyze bleeding related complications among patients on antiplatelet therapy (apt).No complaints for the subject device were reported.This event has been reported by the importer on mdr# 2951238 - 2021 - 00299.

Event Description

It is reported in the journal article titled "the effect of antiplatelet agents on bleeding related complications following ureteroscopy" nine of 314 patients from the study group had ureteroscopy performed (while receiving anti-platelet therapy) using one of five listed scopes including an olympus urf-p3, and experienced adverse events.Of the nine patients experiencing adverse events, five patients experienced what was classified as a significant bleeding event:(1) procedure termination explicitly due to bleeding and difficult visualization resulting in a second operative intervention; (2) unplanned, immediate postoperative admission for bleeding; (3) ed visit for hematuria; (4) subsequent hospital admission for hematuria management (after dismissal home post-procedure); and 5) unplanned return to the or for evaluation of ongoing bleeding.No patient required a blood transfusion.One patient experienced a non-significant bleeding event, with no treatment required.Two patients were re-admitted post-procedure for fever/bacteremia (treatment not specified).One patient was re-admitted post procedure for abdominal pain, nausea and vomiting (treatment not specified).This is a retrospective study from 2009-2016 and there is no specific information regarding which scope was used in each case.This report is being submitted to report the potential that an olympus device could have caused or contributed to an adverse event in one of the nine patients who experienced an adverse event.There is no report that the urf-p3 malfunctioned in any way.

• Brand Name: OES URETERORENOFIBERSCOPE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• 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: 11465491
• MDR Text Key: 250652554
• Report Number: 8010047-2021-03599
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403811
• UDI-Public: 04953170403811
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: URF-P3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other