MAUDE Adverse Event Report: GYRUS ACMI INC. PLASMAKINETIC PK BUTTON FRONT LOADING ELECTRODE; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE

Model Number 786500

Device Problem Charred (1086)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2016

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The cause of the reported event could not be conclusively determined at this time.

Event Description

Olympus was informed that during a transurethral resection of the prostate (turp) procedure, the surgeon smelled a wire burning and observed sparks while holding the pk button electrode unit.There was no injury to the patient or user.The intended procedure was completed using a different but similar device.The facility reported that after disassembling the device, a black burn mark was found on the proximal button electrode and also at the orange power cord connector.

• Brand Name: PLASMAKINETIC PK BUTTON FRONT LOADING ELECTRODE
• Type of Device: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE
• Manufacturer (Section D): GYRUS ACMI INC.; 136 turnpike road; southborough MA 01882 2104
• Manufacturer Contact: donny shapiro ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355161
• MDR Report Key: 5497304
• MDR Text Key: 40253657
• Report Number: 2951238-2016-00224
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2016

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: 786500
• Device Catalogue Number: 786500
• Device Lot Number: U1508019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2016
• Initial Date FDA Received: 03/14/2016
• 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