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

Model Number URF-V2

Device Problems Break (1069); Nonstandard Device (1420)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The referenced scope was returned to olympus for evaluation. A visual inspection was performed on the received scope and confirmed a broken bending section near the insertion tube side. The bending cover has partially torn at the broken bending section rib. There was a slight bend on the bending section rib that is lifted away from the bending section. The light guide bundle, sheath, ccd unit cover sheath have damaged at the same location of the broken bending section. There was no evidence of fluid in the bending section. The scope does not seem to have been used by the customer. The scope was shipped to the user facility on october 10, 2018 and the user facility reported the bending section damage on october 11, 2018. A review of the instrument history shows the scope was last in for service on (b)(6) 2018. The cause of the reported event could not be confirmed, however, olympus will continue to investigate. If additional information becomes available, this report will be updated accordingly.

Event Description

Olympus was informed that upon receipt of the loaner scope, the bending section at the distal end was observed to be damaged upon opening the box. There was no patient involvement with the reported scope.

• 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: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8044800
• MDR Text Key: 128608305
• Report Number: 2951238-2018-00672
• Device Sequence Number: 0
• Product Code: FGB
• Reporter Country Code: US
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/06/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/06/2018
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: URF-V2
• Device Catalogue Number: URF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1251-2017