MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS COOPERATION ELECTROSURGICAL UNIT

Model Number UES-40

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to olympus yet.According to the user facility, the saline connector on of the subject device and the a cord connected to the subject device melted.So there was a possibility that the saline connector generated abnormal heat.The cause of the abnormal heat in the saline connector was assumed in following 2 items.The saline connector of the ues-40 generated heat because the a cord produced abnormal heat by its wire disconnection.The saline connector of the ues-40 generated heat due to electrical short circuit inside the saline connector attributed to the saline solution scattered over the saline connector.Olympus also checked the device history record of the subject device, and there was no irregularity found.The instruction manual of this device already mentions that wire disconnection in the a cord may result in abnormal heating and that an operator should keep liquids away from all electrical equipment.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

During the saline resection, the operation room filled with a smell of burning when the user facility used the subject device.The user facility completed the procedure with replacing the subject device to another device.The user facility confirmed the saline connector on the front panel of the subject device and the a cord connected to the subject device melted.The patient was awake when the phenomenon occurred, but there was no patient injury in this event.

• Brand Name: ELECTROSURGICAL UNIT
• Type of Device: ELECTROSURGICAL UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS COOPERATION; 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: 5499707
• MDR Text Key: 40304481
• Report Number: 8010047-2016-00343
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2016

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: Health Professional
• Device Model Number: UES-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2010
• 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