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

Model Number URF-P7R

Device Problem Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to (b)(4).(b)(4) evaluated the subject device and confirmed that black dots were displayed on the endoscopic image of the subject device and there was a crack on the lens of the subject device.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during a retrograde intrarenal surgery, black dots were displayed on the endoscopic image of the subject device.It was reported that the user facility was using a laser device when the event occurred.The user facility changed the subject device and the procedure was completed with another device.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.On august 6th, 2019, olympus medical systems (b)(4) additionally evaluated the subject device and the additional evaluation results were as follows; there was a leak from the object lens.There was a burn mark at the distal end.There was corrosion inside the bending tube.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Considering the burn mark at the distal end, it is likely that the image fiber breakage, lens cracking, and leakage from the object lens occurred due to erroneous irradiation of the laser inside the subject device.It is surmised that the reported event occurred due to the image fiber breakage.The instruction manual of the device has already warned as follows; do not irradiate the laser without viewing the tip of the laser probe and the aiming beam in the endoscopic image.This may cause patient injury, and the instrument channel may be damaged.Do not withdraw the laser probe while irradiating the laser.Patient injury and/or endoscope damage may occur.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• 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: 8854247
• MDR Text Key: 195245827
• Report Number: 8010047-2019-02810
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403835
• UDI-Public: 04953170403835
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P7R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/25/2018
• 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