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

Model Number URF-V2R

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to the service center for evaluation. The scope failed the leak test due to bending section cover glue. The bending section rubber was found to have a hole/cut. There was no pass between the forceps and brush passage. The bending section was found broken with sharp metal sticking out. The scope¿s angulation was checked and found to be very low. All switches were found functional and the image was normal. The instruction manual for the urf-v2r provided statements to mitigate damage to the scope¿s bending section. Do not bend, hit, pull, or twist the insertion section, bending section, control section, universal cord, video cable, video connector, and light guide connector. The endoscope may be damaged, and water leakage and/or breakage of internal parts like the image sensor cable can result. Do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector. Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector with excessive force. The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations. It could also cause parts of the endoscope to fall off inside the patient. Never perform angulation control forcibly or abruptly. Never forcefully pull, twist, or rotate the angulated bending section. Patient injury, bleeding, and/or perforation may result. It may also become impossible to straighten the bending section during an examination. Do not twist or bend the bending section with your hands. Equipment damage may result. Do not squeeze the bending section forcefully. The covering of the bending section may stretch or break and cause water leakage.

Event Description

The service center was informed that during reprocessing, the scope was noted to be damaged. There was no report of patient involvement.

• 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: 10932050
• MDR Text Key: 219163610
• Report Number: 8010047-2020-09683
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: URF-V2R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse