MAUDE Adverse Event Report: MEDTRONIC, INC. AQUAMANTYS ®; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number 23-112-1

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2018

Event Type  malfunction  

Event Description

Defective supply; tubing had a hole.New supply had to be opened to the field to complete the procedure.Product had patient contact but no patient harm.Manufacturer response: for sealer aquamantys bipolar 6.0, (brand not provided) (per site reporter).Left voicemail for customer service.Need rma number to return failed product to the manufacturer.

• Brand Name: AQUAMANTYS ®
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): MEDTRONIC, INC.; 180 international drive; portsmouth NH 03801
• MDR Report Key: 7373207
• MDR Text Key: 103560945
• Report Number: 7373207
• Device Sequence Number: 1
• Product Code: GEI
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 23-112-1
• Device Lot Number: PHJ207LO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/05/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR