MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION SONOSURG-G2; 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 10/15/2014

Event Type  malfunction  

Event Description

During procedure, the subject device shut down.Upon the investigated, the fuse was blown.The intended procedure was completed with a different device.

Manufacturer Narrative

The subject device was returned to olympus medical systems corp (omsc) for evaluation.The evaluation confirmed that the fuse of the subject device blew and fet (field-effect transistor) of amplifier substrate was damaged.The manufacturing history was reviewed, with no irregularities noted.Based upon the evaluation result and the past similar cases, since there were the incidental failure or the variation of fet, fet was damaged and the fuses blew.The sonosurg-g2 instruction manual already states.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 (b)(6) 2015.This is a supplemental report for mfr report #8010047-2014-00650 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
• 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: 4250162
• MDR Text Key: 21932580
• Report Number: 8010047-2014-00650
• 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: Foreign,Health Professional,User Facility,foreign,health profe
• 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: 10/28/2014
• Initial Date Manufacturer Received: 10/15/2014
• Initial Date FDA Received: 11/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1