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

Model Number CYF-V2

Device Problems Mechanical Problem (1384); Difficult to Remove (1528)

Patient Problem Injury (2348)

Event Date 01/17/2019

Event Type  Injury  

Manufacturer Narrative

As part of our investigation, multiple follow up attempts were made via telephone and in writing to contact the user facility to obtain addition information regarding the patient, procedure and scope but no information has been obtained to date. The scope was returned to olympus but the evaluation is in progress. Olympus will continue to investigate the reported event. If additional information becomes available, this report will be updated accordingly.

Event Description

Olympus was informed that during a procedure, a scope became stuck inside the patient¿s urethra. The scope¿s insertion tube was in a 360 degree loop and the up lever worked but the down lever did not move the bending section tip of the scope. The physician had decided to cut the scope¿s insertion tube and had to rush the patient into surgery.

• 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: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8324293
• MDR Text Key: 135678199
• Report Number: 2951238-2019-00429
• 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: COMPANY REPRESENTATIVE,HEALTH

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/24/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 02/08/2019
• Is This An Adverse Event Report?: Yes
• 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: 01/23/2019
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/12/2019
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 10/20/2014
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient TREATMENT DATA

Date Received: 02/08/2019 Patient Sequence Number: 1