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 02/14/2014

Event Type  malfunction  

Event Description

Olympus medical systems corp (omsc) was informed that during pancreaticoduodenectomy, the subject device could be recovered by re-booting up, the physician used it for a while.However, at the letter half of the surgery, the same phenomenon recurred.The surgery was completed with a similar device.There was no report injury regarding this event.

Manufacturer Narrative

The subject device was returned to omsc for evaluation.The evaluation confirmed that the event could not be duplicated and the subjected device passed for all functional tests.There were not any malfunctions on the subject device.The manufacturing history was reviewed, with no irregularities noted.As the result of the evaluation, since there were not any malfunctions on the subject device, we could not determine the cause of this event.The device connection or power source environment at the facility cannot be ruled out as a contributory factor to this event.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: SONOSURG-G2
• Type of Device: ULTRASONIC SURGICAL SYSTEM
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 3772598
• MDR Text Key: 4357579
• Report Number: 8010047-2014-00126
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2014

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: 02/24/2014
• Initial Date Manufacturer Received: 02/14/2014
• Initial Date FDA Received: 03/14/2014
• 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
• Type of Device Usage: Reuse
• Patient Sequence Number: 1