MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "CYF-V2", EUROPEAN VERSION; CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-V2

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus (b)(4).(obv).In the evaluation of obv the following was confirmed in the instrument channel; there was no foreign materials, but there was a lot of debris derived from the instrument channel material.Kinked at 20 cm from the distal end.There was heavy scratches.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 from a facility that it felt particles had come out of the subject device during a therapeutic procedure.There was no patient injury associated with this report.

• Brand Name: VIDEOSCOPE "CYF-V2", EUROPEAN VERSION
• 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: 9449137
• MDR Text Key: 219779197
• Report Number: 8010047-2019-04239
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2019

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: No Information
• Device Model Number: CYF-V2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1