MAUDE Adverse Event Report: GYRUS ACMI, INC MONOPOLAR ACTIVE CORD, BOVIE/VALLEYLAB GENERATORS

Model Number C650-129A

Device Problems Break (1069); Charred (1086)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2017

Event Type  malfunction  

Manufacturer Narrative

The cord was not returned to olympus for evaluation; however, a review of the photo images provided from the user facility confirms that the cord detached from the black connector.The exact cause of the reported event can be determined at this time.Based on similar reports, the operator¿s techniques and user handling cannot be ruled out as contributory factors to the reported event.The instruction manual warns users ¿examine this cord 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 a therapeutic cystoscopy procedure, smoke and a burning smell were noted at the connection point of the active cord and electrode.Upon inspection it was noted that the charred cord had broken away from the connector.There were no sparks or flames observed.The intended procedure was completed.There was no user or patient injury reported.Additionally, the user facility reported that the cord was approximately 4-5 years old.

• Brand Name: MONOPOLAR ACTIVE CORD, BOVIE/VALLEYLAB GENERATORS
• Type of Device: MONOPOLAR ACTIVE CORD, BOVIE/VALLEYLAB GENERATORS
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6983522
• MDR Text Key: 91120050
• Report Number: 2951238-2017-00706
• Device Sequence Number: 1
• Product Code: FAS
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2017

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: 10/09/2017
• Initial Date FDA Received: 10/27/2017
• 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