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

Model Number URF-P7

Device Problem Display Difficult to Read (1181)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus (b)(4) before the subject device was returned to olympus medical systems corp.(omsc).According to the investigation by ofr, it was found that two cable supports in the bending section were peeled off.The subject device has been returned to omsc for evaluation now.However, the evaluation is in progress at this time.The exact cause of the reported event could not be conclusively determined at this time.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

At an unspecified timing, more than 20 black dots were displayed on the endoscopic image.There was no report of the patient¿s injury regarding this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) investigated the subject device and concluded as the following.About the black dots displayed on the endoscopic image: omsc considered that the stress was applied to the image guide bundle and the image guide was broken.About the cause of cable support peel-off: during the procedure to access the inferior calyx of kidney, the angle operation was forcibly performed with the distal end fixed inside the kidney.As a result, the cable support was stressed and peeled off from the bending section.The device history record indicates that the subject device has been shipped in conformity to the specifications.There were no further details provided.If significant additional information is received, 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 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: 9222532
• MDR Text Key: 194446938
• Report Number: 8010047-2019-03666
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P7
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/23/2019
• Supplement Dates Manufacturer Received: 10/24/2019
• Supplement Dates FDA Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2018
• 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