MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER LIGASURE EXACT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number LF2019

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, post thyroidectomy, the device tip was broke and that broken part was missing, an x-ray was done to the patient to check but no fragment found inside.

• Brand Name: LIGASURE EXACT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 8691358
• MDR Text Key: 147731598
• Report Number: 1717344-2019-00749
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 20884521741093
• UDI-Public: 20884521741093
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF2019
• Device Catalogue Number: LF2019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention