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

Model Number URF-P6R

Device Problem Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.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, the user facility noticed that black dots were displayed on the endoscopic image of the subject device, and it was necessary to replace the device.The intended procedure was completed with a similar device.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information and correct the section g4 ¿date received by manufacturer¿.On april 25th, 2019, olympus received the following information from the user facility.Black dots were displayed on the endoscopic image of the subject device during a retrograde intrarenal surgery.The doctor had to remove the subject device from the patient during the procedure.The intended procedure was completed with a similar device.Therefore, the rec¿d by mfr "date received by manufacturer" has been changed to (b)(6) 2019 from (b)(6) 2019.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus medical systems india private limited (omsi).Omsi evaluated the subject device and confirmed as follows; there was an air leak from the bending section rubber at the position where the bending section was broken.There was no major dent in the insertion tube or the distal end.There was no remarkable dent or the hitting dent on the subject device.The last repair was carried out for the device on march 11th, 2019.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.

• 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
• MDR Report Key: 8643418
• MDR Text Key: 146388602
• Report Number: 8010047-2019-02024
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1