MAUDE Adverse Event Report: GYRUS ACMI INC. PK PLASMABUTTON; PK PLASMA BUTTON ELECTRODE

Model Number 786500

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2015

Event Type  malfunction  

Event Description

The physician had trouble getting the handpiece to work properly.

• Brand Name: PK PLASMABUTTON
• Type of Device: PK PLASMA BUTTON ELECTRODE
• Manufacturer (Section D): GYRUS ACMI INC.; 136 turnpike rd; southborough MA 01772
• MDR Report Key: 5008482
• MDR Text Key: 23192532
• Report Number: 5008482
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 786500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR