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

Model Number CYF-V2

Device Problem Material Deformation (2976)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/21/2022

Event Type  Injury  

Event Description

The customer reports during an unspecified procedure using a cyf-v2 videoscope, the device curled into a knot.It reported the patient was injured.No information was provided regarding type/location/severity of the injury or if/what treatment was required as a result.Additional information has been requested.At this time no additional information has been provided.

• Brand Name: VIDEOSCOPE "CYF-V2", UK 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
• MDR Report Key: 14164476
• MDR Text Key: 289734354
• Report Number: 2951238-2022-00384
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339431
• UDI-Public: 04953170339431
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2022,04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/24/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other