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 12/05/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus medical systems corp.For evaluation.The manufacturing history of the subject device was reviewed, with no irregularities noted.Therefore the exact cause of the reported event could not be conclusively determined at this time.If additional information or the device is received a later time, this report will be supplemented.

Event Description

The subject device was used for an uncertain procedure.The subject device shut down suddenly during a procedure.The procedure was completed with another device, and there was no patient injury reported.

Manufacturer Narrative

The subject device sonosurg-g2 set is connected to the sonosurg connection cable maj-1121, maj-1121 is connected to the transducer t2h-c, and t2h-c is connected to the scissors.The subject device, maj-1121 (lot #57k), and t2h-c (sn (b)(4)) were returned to olympus for evaluation.The part of maj-1121 connected to t2h-c was detached from maj-1121.The adhesive which fixes the part was discolored to brown and hardly remained.Judging from these results, it is considered that the subject device shut down since the connection with maj-1121 and t2h-c was electronically terminated.It seems that the part was detached from maj-1121 since a pulling load was added to a socket of maj-1121 to connect t2h-c repeatedly at the state that adhesive deteriorated.The cause that adhesive deteriorated was not identified, but it might be the autoclaving while cleaning liquid remained due to inadequate rinsing of reprocess.It is considered that pulling load of socket occurred when scissors and t2h-c were removed from maj-1121.

• 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: kunimori yamaguchi ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 42 6425177
• MDR Report Key: 5356223
• MDR Text Key: 35492747
• Report Number: 8010047-2016-00029
• 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,Followup
• Report Date: 02/10/2016

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: 01/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2015
• Initial Date FDA Received: 01/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2005
• 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