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

Model Number CYF-VH

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

The subject devices have not been returned to omsc but were returned to (b)(4) (okm). For evaluation. In the evaluation of okm the following was confirmed; the bending section rubber was leaking. The bending section was crushed, detached and rotating. Inserting accesories to the instrument channel was restricted. 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 the following information. During an unspecified procedure using the subject device, the bending section of subject device was broken. The subject device became stuck inside patient and caused difficulty being removed from the patient. The user tried to catheterise the patient but could not pass the catheter into the bladder because of the presence of bladder stones. Since the subject device could not be removed from the patient, the procedure was shifted to an open surgery and the subject device was removed from the patient. Further injuries to the patient on this event have not been reported.

• 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: 9822133
• MDR Text Key: 190037411
• Report Number: 8010047-2020-01764
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: UK
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/10/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 03/12/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: CYF-VH
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/16/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 05/13/2019
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient TREATMENT DATA

Date Received: 03/12/2020 Patient Sequence Number: 1