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

Model Number CYF-VHR

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2018

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to olympus for evaluation.A visual inspection of the device found the bending section cover glue/cement at the distal end side of the insertion tube is cracked, chipped and partially missing exposing the bending section assembly threading.In addition, there is a kink/indentation on the bending section next to the damaged bending section cover glue/cement.The scope passed the leak test.A repair/replacement scope was sent to the user facility.The cause of the reported event could not be conclusively determined, however, based on the evaluation results the damaged glue/cement and kink on the bending section are indicative of user handling.The instruction manual provides warning which states, ¿do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.¿.

Event Description

Olympus was informed that during a cystoscopy procedure, parts of the scope around the bending section are flaking off inside the patient¿s bladder.The device fragments were removed from the patient.No patient injury was reported.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode.

• 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
• MDR Report Key: 7252055
• MDR Text Key: 99937620
• Report Number: 2951238-2018-00089
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: PK062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: CYF-VHR
• Device Catalogue Number: CYF-VHR
• Device Lot Number: N/A
• Other Device ID Number: 04953170310522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1