MAUDE Adverse Event Report: GYRUS ACMI, INC. PK TECHNOLOGY PK PLASMABUTTON ELECTRODE; ELECTROSURGICAL ELECTRODE, UROLOGICAL

Model Number 786500

Device Problem Charred (1086)

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

Event Date 07/11/2017

Event Type  malfunction  

Event Description

During a cystoscopy transurethral resection using loop and button, the surgeon was using a disposable pk button, and it was noted that the instrument was charred.The pk superpulse sp generator stopped as it is designed to.The charred instrument was exchanged with a new instrument and the procedure continued.There was no bleeding/no injury to the patient as the result of this event.There was a ten-minute delay that resulted, while the charred instrument was exchanged for the new disposable hand piece.The patient did not require any additional procedures as a result of this event.The plan is to return the charred instrument to the manufacturer for investigation.The surgical team was unable to determine any sort of root cause for the occurrence of this event.

• Brand Name: PK TECHNOLOGY PK PLASMABUTTON ELECTRODE
• Type of Device: ELECTROSURGICAL ELECTRODE, UROLOGICAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 136 turnpike rd.; southborough MA 01772
• MDR Report Key: 6731812
• MDR Text Key: 80675242
• Report Number: 6731812
• Device Sequence Number: 1
• Product Code: FAS
• 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
• Type of Report: Initial
• Report Date: 07/14/2017

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: No Information
• Device Expiration Date: 02/01/2019
• Device Model Number: 786500
• Device Lot Number: U1603026
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/14/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: GYRUS PK SUPERPULSE GENERATOR
• Patient Age: 81 YR