MAUDE Adverse Event Report: GYRUS ACMI, INC. PK FRONT LOADING SUPERSECT (BOX OF 5); ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number 784515

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

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

Event Date 08/26/2019

Event Type  malfunction  

Event Description

During use of the gyrus supersect electrode we heard a pop then there was an electric smell.

• Brand Name: PK FRONT LOADING SUPERSECT (BOX OF 5)
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC.; 93 north pleasant st.; norwalk OH 44857
• MDR Report Key: 9116566
• MDR Text Key: 160039865
• Report Number: 9116566
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 784515
• Device Lot Number: U1901127
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2019
• Device Age: 13 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29200 DA