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

Model Number SONOSURG-G2

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2015

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, and two of the three fuses were blown.The screw that was the same shape as a screw fixing the board was found fallen off near the board.This screw found and the board were burnt and melted.The subject device had all screws intact.The manufacturing records for this serial number indicated no abnormalities related to the reported phenomenon.Based on the repairing records, it was confirmed that the subject device wasn't repaired.Based upon the evaluation result, it was supposed that two fuses were blown since the screw which fell in the subject device touched a board, and an overcurrent flowed due to the short circuit between a board and the outside panel.The manufacturing year of the subject device was revealed to be 2003 based on the serial number.The cause that the screw fell off was not identified.The subject device is designed that fuses blow to keep safety when an overcurrent occurs.This 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 partial hepatectomy.The subject device shut down after one hour use.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: 5216377
• MDR Text Key: 30993222
• Report Number: 8010047-2015-01064
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2015

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: Physician
• Device Model Number: SONOSURG-G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2015
• Initial Date FDA Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2003
• 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