MAUDE Adverse Event Report: COVIDIEN LLC LIGASURE ATLAS; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number LS1037

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2018

Event Type  malfunction  

Event Description

A ligasure atlas was found to have a piece of plastic towards the tip that curls back and exposes the pulley system when used.The ligasure use was discontinued after this was found, and sent to clinical engineering for evaluation.Images were taken of this defect, and it will be returned to the manufacturer for failure analysis.No harm came to the patient and the procedure was completed as planned with a replacement device.Per site reporter: awaiting response from manufacturer, the device will be returned for failure analysis.

• Brand Name: LIGASURE ATLAS
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7633588
• MDR Text Key: 112198174
• Report Number: 7633588
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884524001630
• UDI-Public: (01)10884524001630
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LS1037
• Device Catalogue Number: LS1037
• Device Lot Number: S7L0020X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Operating Room
• Date Report to Manufacturer: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Weight: 87