MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC SURGICAL SYSTEM SONOSURG; ELECTROSURGICAL UNIT

Model Number SONOSURG-G2 SET

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The evaluation confirmed that the subject device did not turn on, two fuses were blown, and fet (field-effect transistor) of amplifier substrate was damaged and burnt.The manufacturing records for this serial number indicated no abnormalities related to the reported phenomenon.Based upon the evaluation result, it was supposed that this phenomenon occurred since the fet was damaged.It is considered that the fet was damaged since the electric current leaked excessively in the fet.Amount of the leaked electric current depends on the dispersion in the electrical characteristic of fet.Omsc addressed this phenomenon by reducing the dispersion of fet.The subject device instruction manual states the following.Prepare a spare instrument as a backup to ensure that the procedure can be completed without complications in case of a malfunction.

Event Description

The subject device was used for a procedure of a heart blood vessel surgery.Though the user stepped on the foot switch, the activation didn't occurred several times.After that the user irrigated sonosurg-iu that was used together and stepped on the foot switch again.Then the subject device shut down with a strange sound, and smoke occurred.The procedure was completed with another device, and there was no patient injury reported.

• Brand Name: ULTRASONIC SURGICAL SYSTEM SONOSURG
• Type of Device: ELECTROSURGICAL UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 42 6425177
• MDR Report Key: 5466825
• MDR Text Key: 39249666
• Report Number: 8010047-2016-00274
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/29/2016

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: Physician
• Device Model Number: SONOSURG-G2 SET
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Initial Date Manufacturer Received: 02/01/2016
• Initial Date FDA Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1