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

Model Number CYF-V2

Device Problem Material Deformation (2976)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation findings: physical evaluation of the complaint device: a visual inspection of the returned device condition was performed and found, the bending section cover buckle/stretched.In order to test the bending section cover, the inspector placed the bending section between two fingers and proceeded to moderately pull the bending section cover from the insertion tube side up to the distal end.After releasing the bending section cover, it was noted that the cover became buckle/stretched, never returning to its original form.Additionally, the inspector tested the bending section, glue and cover as stated in the inspection standards.The ring gauge was passed over the distal end, and obstruction was found at the section of the bending cover that had become buckled.A review of the device history record (dhr) for the device was conducted and confirmed there were no abnormalities in manufacturing.The instructions for use (ifu) shipped with the device provide the user with the following information related to the reported event: chapter 3 preparation and inspection before each case, prepare and inspect this instrument as instructed below.Inspect other equipment to be used with this instrument as instructed in their respective instruction manuals.If this instrument malfunctions, do not use it.Return it to olympus for repair as described in section 9.3, "returning the endoscope for repair" on page 123.If any irregularity is observed after inspection, follow the instructions given in chapter 9, "troubleshooting".Using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage conclusions: the definitive root cause for this event could not be identified.Investigation results suggest the following possible causes: device degradation.The device was 13 years and 9 months old.The rubber a had deteriorated, and the buoyancy occurred when the rubber was moving during procedure.External force: there is evidence that some external force was applied to the a rubber, damaging the a-rubber and contributing to the movement.

Event Description

It is reported during a cystoscopy using a visera cysto-nephro videoscope, the doctor felt more friction than normal.Upon removing the scope after the exam, the patient had some bleeding.The scope was examined by the customer after the procedure and it was noted on the tip of the flexible portion of the scope, the outer covering of the scope is raised, and formed a ring, and it is not smooth.The procedure was completed as planned.The patient had minimal amount of post-procedure bleeding.No treatment was required as a result of this.The patient's current condition is stable with no continued bleeding.

• Brand Name: VISERA 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: 11130270
• MDR Text Key: 225596239
• Report Number: 8010047-2021-01004
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2007
• 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 Age: 65 YR
• Patient Weight: 100