MAUDE Adverse Event Report: OSTA MONOPOLAR ACTIVE CORD, BOVIE/VALLEYLAB GENERATORS

Model Number C650-129A

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2017

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to olympus for evaluation.The exact cause of the reported event could not be determined at this time; however, the operator¿s technique and user handling of the device could not be ruled out as contributory factors to the reported event.The instruction manual for use states, ¿examine this device prior to use.Do not use if damage is found.Do not use an instrument that fails to meet the criteria stated in the labeling or that has been damaged.¿.

Event Description

Olympus was informed that during an unspecified procedure, a sharp ¿pop¿ sound was heard and smoke was seen.It was also noted that there was a wire separation found at the head of the connector of the device.No report of emergency fire evacuation occurred.The intended procedure was completed using a different device.No user or patient injury reported.

• Brand Name: MONOPOLAR ACTIVE CORD, BOVIE/VALLEYLAB GENERATORS
• Type of Device: MONOPOLAR ACTIVE CORD, BOVIE/VALLEYLAB GENERATORS
• Manufacturer (Section D): OSTA; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6419714
• MDR Text Key: 70417413
• Report Number: 2951238-2017-00168
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2017

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: C650-129A
• Device Catalogue Number: C650-129A
• Device Lot Number: UNKNOWN
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2017
• Initial Date FDA Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1