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

Model Number CYF-V2R

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2017

Event Type  malfunction  

Manufacturer Narrative

No device was returned to olympus for evaluation.Since no serial number and user facility information was provided, olympus was unable to perform an instrument service history review.The cause of the reported event could not be determined.

Event Description

Olympus received a medwatch report (mw5071244) on (b)(6) 2017 stating that during a cystoscopy procedure, an unknown substance coming from the scope was found inside the patient¿s bladder.The patient¿s bladder was drained and there appeared to be an ¿oil emulsion¿ floating in the urine.No patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from nwb to faj and 510(k) number.

• 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
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6840454
• MDR Text Key: 85786370
• Report Number: 2951238-2017-00580
• 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: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

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: Health Professional
• Device Model Number: CYF-V2R
• Device Catalogue Number: CYF-V2R
• Device Lot Number: N/A
• Other Device ID Number: 04953170287619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2017
• Initial Date FDA Received: 09/01/2017
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 03/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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