MAUDE Adverse Event Report: GYRUS ACMI INC GYRUS ACMI PLASMAKINETIC SUPER PULSE SYSTEM; GYRUS PK BUTTON

Model Number 786500

Device Problems Charred (1086); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2015

Event Type  Injury  

Event Description

Per circulating rn: "during turp fulguration smoke was seen and smelled by or crew and md.Procedure immediately stopped.Upon inspection char was noted at point of connection between resectoscope and electrode.New electrode and resectoscope brought in and connected.Case continued with no further problem.No injury to patient.".

• Brand Name: GYRUS ACMI PLASMAKINETIC SUPER PULSE SYSTEM
• Type of Device: GYRUS PK BUTTON
• Manufacturer (Section D): GYRUS ACMI INC; southborough MA
• MDR Report Key: 5187296
• MDR Text Key: 29924558
• Report Number: MW5057477
• Device Sequence Number: 1
• Product Code: FAS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 786500
• Device Catalogue Number: 786500
• Device Lot Number: U1502153
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR