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.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.According to information provided by the facility, when the subject device was removed from the patient's body during the open surgery, the bending section was bent to its maximum angle and a bladder stone was stuck in the bending section.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.

• 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
• 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
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention