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

Model Number CYF-VHR

Device Problems No Display/Image (1183); Material Twisted/Bent (2981)

Patient Problems Tissue Damage (2104); Blood Loss (2597)

Event Date 09/04/2019

Event Type  Injury  

Manufacturer Narrative

The referenced scope was returned to the service center for evaluation.A visual inspection was performed on the received condition and found the bending section at the distal area was dented/kinked near the middle portion.The damage to the bending section is located at approximately 40mm from the distal end side.The image of the scope was inspected by connecting the video scope to a test cv-190 processor and clv-190 light source; with no image anomalies (flickering, loss of image) observed.During the image inspection, the bending section, insertion tube, light guide tube and video cable were periodically manipulated in attempt to replicate a loss of image, which never presented itself.The instrument channel was found twisted and collapsed at the same location of the external damage to the bending section area.Due to the collapse of the bending section and biopsy channel, the brush and forceps are unable to pass through the channel.Furthermore, the scope passed the leak test.Additionally, the bending section cover glue on both ends of the bending section cover were noted as chipped, peeling with some missing bending section cover glue pieces.The light guide tube, video cable and protector boots have various areas of discoloration.Based on the evaluation findings and the information reported, the most probable cause of the bending section damage is due to excessive force.The instruction manual provides warning to mitigate the risk of patient injury and damage to the device.Never perform angulation control forcibly or abruptly.Never forcefully pull, twist, or rotate the angulated bending section.Patient injury, bleeding, and/or perforation may result.It may also become impossible to straighten the bending section during an examination.Do not pull the universal cord and video cable during an examination.The light guide connector will be pulled out from the output socket of the light source and the endoscopic image will not be visible.

Event Description

The manufacturer became aware that during procedure, the doctor inserted the endoscope into the patient's urethra and lost view and went withdraw the endoscope.The endoscope got stuck and became kinked and folded over.The doctor was eventually able to withdraw and straighten the endoscope.As a result, the patient suffered bleeding, urethra trauma and the patient had to be cauterized.

• 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: 9146191
• MDR Text Key: 167086449
• Report Number: 8010047-2019-03455
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411298
• UDI-Public: 04953170411298
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-VHR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 10/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention