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 Type  malfunction  

Manufacturer Narrative

The scope was returned to olympus for evaluation.A visual inspection was performed on the received condition of the scope and found the bending section cover blown/torn apart; the bending section mesh was exposed.There was no damage noted on the distal end cover.In addition, one of the light guide lens has scratches and a chipped mark from the distal tip.As a result, no leak test could be performed.A review of the scope¿s instrument history shows the scope was purchased on (b)(6) 2015 and was last serviced on (b)(6) 2018.The cause of the reported event could not be conclusively determined.However, based on similar reported complaints, the most probable cause of a blown bending section cover can be attributed to improper handling.To mitigate the risk of damage to the scope, the instruction manual provides the 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.As part of our investigation, olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported complaint but no information was obtained.Accordingly.However, if additional information is received this report will be supplemented.

Event Description

Olympus was informed that during a therapeutic procedure, the scope¿s tip broke.There was no patient injury reported.No additional information was provided.

• 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: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8404051
• MDR Text Key: 138257415
• Report Number: 2951238-2019-00523
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170310522
• UDI-Public: 04953170310522
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/08/2019

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: No Information
• Device Model Number: CYF-VHR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 03/08/2019
• 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