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

Model Number CYF-VHR

Device Problems Peeled/Delaminated (1454); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to olympus.As part of the investigation, a review of the device history record (dhr) and a review of the instructions for use (ifu) were conducted.The dhr review did not show any anomalies or abnormalities identified during production.The device met all specifications upon release.The root cause of the event could not be established.Possible causes include an external force, degradation due to aging, or damage due to handling.The ifu contains the following statements: "follow the warnings and cautions given below when handling this instrument.This information is to be supplemented by the warnings and cautions given in each chapter." "after using this endoscope, reprocess and store it according to the instructions given in the endoscope¿s companion ¿reprocessing manual¿ with your endoscope model listed on the cover.Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection." "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." "never perform angulation control, suction control or insertion/withdrawal of the endoscope¿s insertion tube without viewing the endoscopic image.Patient injury, bleeding and/or perforation can result." "never insert or withdraw the endoscope¿s insertion tube while the up/down angulation is locked.Patient injury and/or equipment damage can result." olympus will continue to monitor for similar complaints.

Event Description

It was reported the end of the cysto-nephro videoscope was shredding during reprocessing.No patient involvement or impact to patient care was reported.

Manufacturer Narrative

This supplemental is being submitted to provide the results of the device evaluation.The device was returned to olympus for evaluation and repair.A leak at the bending section sheath and eto valve (valve at the scope connector) was confirmed.The adhesive glue at the bending section was cracked/peeling and exposing threads.The control body was found detached from the bending section.Minor scratches were also noted on the plastic cover and lens.Minor restriction was noted in the brush passage.A minor dent was found on the insertion tube.The conclusions of the investigation were provided in the previous report and remain unchanged.Olympus will continue to monitor for similar events.

• 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: 11605948
• MDR Text Key: 243906776
• Report Number: 8010047-2021-04473
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411298
• UDI-Public: 04953170411298
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

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-VHR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 04/01/2021
• Supplement Dates Manufacturer Received: 04/13/2021
• Supplement Dates FDA Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1