MAUDE Adverse Event Report: GYRUS ACMI, INC. GYRUS PK; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/02/2016

Event Type  malfunction  

Event Description

The patient was in the process of having a robotic sacrocolpopexy, oophorectomy, and enterolysis surgery.The gyrus generator malfunctioned during tissue coagulation.The patient remained stable during this procedure.The device was removed from the operating suite and replaced with a working device.Management was notified, the device was tagged and a work order was placed.Gyrus generator was not working properly during procedure.The generator was switched with another working unit without any further malfunctions.

• Brand Name: GYRUS PK
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC.; 2925 appling rd.; bartlett TN 38133
• MDR Report Key: 6442422
• MDR Text Key: 71149518
• Report Number: 6442422
• Device Sequence Number: 1
• Product Code: KNS
• 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: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR