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

Model Number URF-V2

Device Problem Material Puncture/Hole (1504)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The device was visually inspected and the bending section skeleton tab was noted to be protruding from the bending section cover at the insertion tube side.The bending section cover was removed and the skeleton was noted to be detached/broken with no signs of any sharp edges.The protruding skeleton tab caused a leak to the bending section cover.Additionally, the whole insertion tube, bending section cover and glue were all observed to be non-olympus parts, which most probably caused the bending section skeleton to break as a result to the user's experience.Per the instructions for use (ifu), ¿using incompatible equipment can result in patient or operator injury and/or equipment damage".

Event Description

It was reported that during preparation for use, the bending rubber over the bending section of the device was found to be damaged.A hole was suspected to be in the bending rubber.

Manufacturer Narrative

Corrected data: this issue was found during device decontamination and not during preparation for use as previously reported.A device history record review was completed and showed the device met all specifications when shipped.The instructions for use (ifu) state, " inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities"."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".It was determined in the device evaluation the presence of non olympus parts and repairs made to the device.Repair work which deviated from ifu, may have caused the reported event as the 'a-rubber' was a non-olympus product.Per the device troubleshooting guide : as repair performed by persons who are not qualified by olympus could cause patient or user injury and/or equipment damage.

• 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: 10103107
• MDR Text Key: 214583260
• Report Number: 8010047-2020-02987
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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