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

Model Number URF-P5

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The evaluation of the subject device by (b)(4), the evaluation confirmed as follows: there were air leaks from the bending section rubber.The bending rubber was folded up to the distal end.There were black dots in the endoscopic image due to the damage of image fiber.The outer surface of the insertion tube was damaged as a whole.The mesh braid inside the insertion tube was partially deformed and crushed.Omsc reviewed the manufacturing history 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 an unspecified procedure, the subject device was stuck within a non-olympus ureteral access sheath (manufacturer: bard medical, size: 10/12 fr.) and they found the access sheath damaged.At the time, they attempted to remove them from the patient.It is unknown whether the procedure was completed or not.Other information was not provided.There was no report of injury associated with this report.The subject device has not been returned to omsc, but was returned to olympus (b)(4) for evaluation.During the evaluation, (b)(4) confirmed that the insertion portion of the subject device stuck within the ureteral access sheath and a metal wire was sticking out from the ureteral access sheath.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code" of d2.

• Brand Name: OES 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: 8284178
• MDR Text Key: 134581643
• Report Number: 8010047-2019-00968
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1