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

Model Number URF-V3

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2021

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed during the incoming inspection for repair at olympus (b)(4), that it was found the metal part of the bending section of the subject device was lifted and its metal part was exposed.The subject device was returned to olympus australia for repair of the leakage at the distal end.There was no report of patient injury associated with the event.

Manufacturer Narrative

The subject device was returned to olympus (b)(4) but has not been returned to omsc.Olympus (b)(4) checked the subject device for evaluation.It was confirmed that the metal part of the bending section of the subject device was lifted and the broken metal part stuck out from the bending section.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The root cause of the reported phenomenon could not be identified.However based on the following information, omsc presumed that the cause of the reported phenomenon was the bending tube of the subject device was damaged because the user operated the bending section with excessive force.-according to device inspection result of olympus australia, the cable support of the bending tube was disconnected.-according to ifu (the instructions for use), if the angle is applied in the opposite direction when the distal end of the scope does not move, the bending section may be damaged.-according to a similar former case, the bending tube was damaged and popped out of the bending rubber because the user operated the bending section with excessive force.-according to capa history review, the bending tube got broken due to¿ user forcibly angulate the distal end toward the opposite direction while the distal end is bent and unable to move in calix.If additional information becomes available, this report will be supplemented.

• 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: 12669608
• MDR Text Key: 281427186
• Report Number: 8010047-2021-13450
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: URF-V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1