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

Model Number CYF-VHR

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.A visual inspection was performed on the returned device and the bending section cover glue from the distal end and insertion tube side cracked with portions of the cement missing/broken off.The missing/broken off cement was not returned.There were scratches noted on the bending section cover glue, which likely cause the damage to the cement.The scope¿s biopsy channel was inspected with olympus telescope and no missing parts or foreign objects/materials were noted inside the channel.Based on the reported complaint the cause of the damage on the bending section cover cement is due to mishandling 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 an unspecified procedure, a piece of the scope¿s distal tip fell inside the patient's bladder.It is unknown if the device fragment was retrieved or if the intended procedure was completed.

Manufacturer Narrative

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

• 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: 7937063
• MDR Text Key: 123201997
• Report Number: 2951238-2018-00607
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310522
• UDI-Public: 04953170310522
• Combination Product (y/n): N
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• 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: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-VHR
• Device Catalogue Number: CYF-VHR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• 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