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

Model Number URF-V3R

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

Patient Problem Tissue Damage (2104)

Event Date 12/03/2019

Event Type  Injury  

Manufacturer Narrative

The referenced scope was returned to the service center but the evaluation is in progress.A review of the service history indicates the loaner scope was last serviced on (b)(6) 2019.The scope was inspected and returned to stock.If additional information becomes available, this report will be supplemented accordingly.This reported event has been reported by the importer on mdr 2951238-2019-01237.

Event Description

The sales representative was informed by the user facility that during a procedure, the metal tip on the scope ripped the patient's ureter.The sales representative further reported that the user facility has been performing procedures using the scope as part of an evaluation to purchase the equipment.The sales representative observed the procedures as the evaluation went on for 5-6 days.There were no reported issues with the scope and no issues with any of the patients during the evaluation.However, on the last day of the evaluation a technician reportedly informed the sales representative that the facility was done with the evaluations and stated the doctor tore a patient's ureter.The sales representative has not been able to obtain additional information from the user facility regarding the reported patient injury.

Manufacturer Narrative

A visual inspection was performed on the scope as the bending section cover, insertion tube, light guide and video cable were inspected but there were no damages observed to the external areas of the scope.The distal end (metal tip) was fully intact and not missing any pieces, nor sharp.The bending section cover glue had no signs of peeling or other damages.A leak test inspection was performed and a leak was observed from the distal end side of the instrument channel.The inside of the instrument channel was inspected; a scrape and tear marks were found at the distal end side upon entering the channel.The most probable cause of the damaged/leaking instrument channel could be attributed to operational use; for example: when inserting an open or broken instrument into the channel.However, based on the evaluation results, the reported patient injury could not be determined as the distal end (metal tip) was fully intact and not missing any pieces, nor sharp.

• 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
• MDR Report Key: 9530200
• MDR Text Key: 189000856
• Report Number: 8010047-2019-04668
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403392
• UDI-Public: 04953170403392
• Combination Product (y/n): N
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: URF-V3R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention