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

Model Number URF-V3

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The referenced scope was returned to the manufacturer for evaluation.A visual inspection was performed on the scope; there was an irregular shape on the bending section at the distal end.The irregular shape on the bending section appears both in the neutral and up angulated positions.When engaging the control lever the movement of the bending section is abnormal in the up direction; down angulation has no response while attempting to manipulate the lever.A microscope inspection was performed on the skeleton of the bending section and discovered that some of the cable supports have detached from the up and down angle wires or partially detached from the wires.The cable support pins that have receded and become detached (partial and full) from the angle wire have caused the bending section to become an irregular shape.The damage to the cable support pins can potentially occur if excessive force is used to manipulate the bending section whenever it becomes stalled.The scope was leaking from the biopsy channel.An olympus boroscope was then used to inspect the biopsy channel and found multiple tear marks at the opening of the channel from the distal end side at approximately 20 mm.The scope was purchased on (b)(6) 2019 accumulating seven uses since.The cause of the reported event could not be determined at this time.The scope will be forwarded to the original equipment manufacturer (oem) for further investigation.

Event Description

During an in-service conducted by the manufacturer, it was determined that the distal tip of the scope was damaged as the up angulation was not working.There was no patient involvement with the subject scope as the scope was removed and sent for service.It was reported that the customer received the instruction for safe use manual.

Manufacturer Narrative

The scope was returned to the original equipment manufacturer (oem) for further investigation.The bending tube was confirmed to be bent towards the up-side as the angulation system was straining continuously between the 1st and 3rd cable support from distal tip.In addition, the 3rd cable support was detached on up-side of bending section.And the up-angulation coil in control unit was out of place.The exact cause of the reported event remains unknown, however, based on the investigation findings, the following factors can potentially contribute to the cause: bending unit not working.(during procedure).Extreme bending.(during procedure).Repeated angulations.(user handling).Strained a-wire.(variation in production).Longer length of coil-pipe.(variation in production).As a preventive measure, the instruction manual indicates the following chapter 4 operation:4.1 precautions: never insert or withdraw the endoscope under any of the following conditions.Patient injury, bleeding, and/or perforation can result.For example, while the endotherapy accessory extends from the distal end of the endoscope (except for using an ureteroscope sheath dilator).While the bending section is locked in position.Insertion or withdrawal with excessive force.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the dhr review.The oem conducted a review of the dhr which indicated there was no anomalies during manufacturing process.

• 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: 8680235
• MDR Text Key: 147644920
• Report Number: 2951238-2019-00920
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403385
• UDI-Public: 04953170403385
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: URF-V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1