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

Model Number CYF-V2

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Urinary Tract Infection (2120)

Event Date 07/27/2021

Event Type  Injury  

Event Description

It is reported by the customer "black pieces are coming out of solution" in connection with two cyf-v2 videoscopes.The customer further states patients have urinary tract infections.Additional details regarding the patient(s) and reported event(s) have been requested.At this time, no additional information has been provided.Case with patient identifier (b)(6) reports one cyf-v2 scope.Case with patient identifier (b)(6) reports one cyf-v2 scope.

• Brand Name: VISERA CYSTO-NEPHRO 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: 12379827
• MDR Text Key: 268646430
• Report Number: 2951238-2021-00387
• 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: 08/05/2021,08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/05/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other