MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION SONOSURG-G2 SET ; ULTRASONIC SURGICAL SYSTEM

Model Number SONOSURG-G2

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2014

Event Type  malfunction  

Event Description

During procedure, the subject device shut down.Upon the investigation, the fuse was found to be blown.The intended procedure was completed with a different device.

Manufacturer Narrative

The subject device was returned to olympus medical systems corp (omsc) for eval.The eval confirmed that the two fuses of the subject device were blown and fet (field-effect transistor) of amplifier substrate was damaged.The mfg records for this serial number indicated no abnormalities related to the reported phenomenon.Based upon the eval result, the two fuses were blown and the subject device shut down due to the damage of fet.This report is being submitted as a medical device report in an abundance of caution.

Manufacturer Narrative

Olympus medical systems corporation (omsc) performed a mdr retrospective review and omsc found that this supplemental report is required on december 7, 2015.This is a supplemental report for mfr report #8010047-2014-01100 to provide device evaluation results.Olympus performed further investigation for the cause of the fet (field effect transistor) damage and the damaged fet had excessive current leakage.The amount of the leakage current depends on the electrical characteristic variability of the fet.Olympus implemented a countermeasure for this phenomenon to reduce the electrical characteristic variability of the fet.

• Brand Name: SONOSURG-G2 SET
• Type of Device: ULTRASONIC SURGICAL SYSTEM
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 4379500
• MDR Text Key: 18927928
• Report Number: 8010047-2014-01100
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 12/28/2015

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: SONOSURG-G2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/08/2014
• Initial Date Manufacturer Received: 11/27/2014
• Initial Date FDA Received: 12/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1