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

Model Number URF-P7

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at the olympus local service department on may 25, 2021, it was found that the coating of the insertion tube of the subject device had been partially peeled off.Other detailed information was not provided.There was no report of patient injury associated with the event.This device is an olympus asset.

Manufacturer Narrative

The subject device was returned to the olympus local service department.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Omsc was informed user information following.San joan hospital center s.I.E.Inst.Equipamentos portugal device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Olympus medical systems corp.(omsc) was informed that the insertion tube of the subject device was scratched.Omsc surmised that the reported phenomenon occurred due to physical stress and other on the insertion tube due to the user handling and other.

• 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: 12914811
• MDR Text Key: 285986902
• Report Number: 8010047-2021-15391
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: URF-P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 12/02/2021
• Supplement Dates Manufacturer Received: 12/08/2021
• Supplement Dates FDA Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2018
• 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