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

Model Number URF-V2R

Device Problems Material Separation (1562); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The device was visually inspected and the reported user facility report of bending rubber coming off was confirmed.Visual inspection results that the bending section cover was torn and partially missing material near the distal end.Additional testing found that the bending section cover damage caused the video scope to leak.The distal end frame was found to have a dent and the rubber (bending section cover-glue) and cement were identified as non-olympus material.The device was serviced and returned to the user facility.

Event Description

The user facility reported that bending rubber came off during a patient procedure.The customer reported that the scope was inspected by surgeon prior to insertion in ureter.It was reported that upon insertion into ureter and bladder, the surgeon observed foreign debris.The surgeon removed as much debris as possible and a x-ray was obtained.It was reported that upon post surgery x-ray review no apparent foreign object was observed.There was no patient harm reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer reported that from the investigation result, there is a trace of a-rubber and gluing part repair done by a party that is not certified by olympus.As a consequence, the subject device was not in a condition that the durability is guaranteed by olympus.It is presumed that non-genuine a-rubber and gluing part was damaged by the physical and chemical stress.The legal manufacturer reported that the caution about a third party repair is described in the ifu.It is recommended to re-instruct the customer that repair should be performed by persons who are qualified by olympus.As well as how to inspect the scope for damage.Effect of misuse the following detecting method for the subject event is described in the ifu.It is determined that the reported event was properly detected according to the ifu.3.3 inspection of the endoscope : 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.The ifu has the following description regarding repair.It was confirmed that the repair done to the device deviated from the ifu.5.2 troubleshooting guide: as repair performed by persons who are not qualified by olympus could cause patient or user injury and/or equipment damage.As the result of dhr review done by mbc, the subject device¿s conformity to the shipping test was confirmed.

• 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: 10226727
• MDR Text Key: 224633060
• Report Number: 8010047-2020-03852
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: URF-V2R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2020
• 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