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 05/20/2020

Event Type  Malfunction  

Manufacturer Narrative

The device was returned to olympus repair center for evaluation. The evaluation of the device confirmed the following: instrument channel port had an additional attached fitting maj-891. The maj-891 is attached to the device before a procedure, and removed during reprocess. When the maj-891 was removed, the instrument channel port came away from the device. The manufacturing history (dhr) confirmed no irregularity. Omsc guessed that the reported event was caused by the excessive stress occurred when putting on, and taking off the maj-891. There is possibility that the excessive stress was caused by user handling. If additional information becomes available, this report will be supplemented.

Event Description

Instrument channel port of the device was loose. There was no report of patient injury associated with this event.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10571071
• MDR Text Key: 208829970
• Report Number: 8010047-2020-06752
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: USER FACILITY

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/23/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 09/22/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: CYF-240
• Was Device Available For Evaluation?: Yes

Is The Reporter A Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 07/06/2010
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse