MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS CYSTO VIDEOSCOPE; CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-240

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2020

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.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair of the subject device at the service department of olympus keymed, it was found the instrument channel port of the subject device had been loosened.There was no report of patient injury associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the information from olympus keymed there was the possibility that the reported phenomenon was attributed to the excessive twisted stress being applied to instrument channel port and the parts around it due to the user handling.If additional information becomes available, this report will be supplemented.

• Brand Name: EVIS CYSTO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10571967
• MDR Text Key: 208108655
• Report Number: 8010047-2020-06763
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CYF-240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1