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

Model Number CYF-VH

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device had not been returned to olympus medical systems corp.(omsc) but was returned to olympus (b)(4).As the evaluation is in progress, the exact cause of the reported event could not be conclusively determined at this time.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.If additional information is received, this report will be supplemented.

Event Description

Olympus was informed that the endoscopic image of the subject device disappeared during an unspecified therapeutic procedure.The facility did not provide detailed information of the event, but there was no report of patient injury associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation result.The subject device had not been returned to olympus medical systems corp.(omsc) but was returned to olympus europa (b)(4).In the evaluation, the reported phenomenon was not duplicated but the evaluation was confirmed followings; - the distal end unit had detached from the bending tube.- the venting connector unit loosened and became rotatable.- the lg lenses were scratched and broken there were no other abnormalities in the subject device.The exact cause of the reported event in which the endoscope image had disappeared could not be identified.From similar cases in the past, the abnormalities were surmised to have occurred due to excessive mechanical stresses.The operation manual has already warned; - do not attempt to bend or twist the endoscope¿s insertion section with excessive force.The insertion section may be damaged.- do not apply shock to the distal end of the insertion section, particularly the objective lens surface at the distal end.Visual abnormalities may result.- do not bend, hit, pull, or twist the insertion section, bending section, control section, universal cord, video cable, video connector, and light guide connector.The endoscope may be damaged, and water leaks and/or breakage of internal parts like the image sensor cable can result.If additional information is received, this report will be supplemented.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• 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
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 7145433
• MDR Text Key: 96019845
• Report Number: 8010047-2017-02090
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2019

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-VH
• Other Device ID Number: 04953170310461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 01/18/2018; 02/13/2019
• Supplement Dates FDA Received: 01/28/2018; 02/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2017
• 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