MAUDE Adverse Event Report: GYRUS ACMI INC. PLASMAKINETIC SUPERPULSE SYSTEM RESECTOSCOPE

Model Number 784515

Device Problems Device Emits Odor (1425); Sparking (2595); Noise, Audible (3273)

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

Event Date 05/26/2016

Event Type  malfunction  

Event Description

During transurethral resection of prostate, as the gyrus bipolar machine was in use, a "spark", followed by a "popping sound" and then a burnt smell was noted emitting from the area where the disposable gyrus loop connects into the working element of the scope.All equipment (disposable loop, scope and gyrus machine) were replaced and the procedure was completed without further incident.

• Brand Name: PLASMAKINETIC SUPERPULSE SYSTEM RESECTOSCOPE
• Type of Device: RESECTOSCOPE
• Manufacturer (Section D): GYRUS ACMI INC. ; southborough ME 01772
• MDR Report Key: 5825585
• MDR Text Key: 50715863
• Report Number: MW5063674
• Device Sequence Number: 1
• Product Code: FJL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 07/22/2016

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 Expiration Date: 02/28/2018
• Device Model Number: 784515
• Device Lot Number: U1603180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR