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

Model Number CYF-VHA

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the facility that the bending section of the subject device was broken during reprocessing after a cystoscopy procedure.The user facility had completed the intended procedure with the subject device.The service department of olympus (b)(4) checked the subject device and found that the distal end was detached from the bending section.There was no report of patient injury associated with this event.

• Brand Name: 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10231319
• MDR Text Key: 197852092
• Report Number: 8010047-2020-03902
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CYF-VHA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2020
• 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: N
• Patient Sequence Number: 1