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

Model Number UNKNOWN LIGASURE INSTRUMENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Gangrene (1873); Hemorrhage/Bleeding (1888)

Event Date 06/01/2018

Event Type  Death  

Manufacturer Narrative

Title: feasibility of vessel sealing devices in surgical excision of vascular malformations - novel approach source: ahmed samir hosny, et al , 2020 , international journal of surgery open.If information is provided in the future, a supplemental report will be issued.[(b)(4)].

Event Description

According to literature source of study performed from january 2015 to june 2018, its aim was to test the feasibility of vessel sealing devices including ligasure exact dissector and other 2 non-medtronic products in the excision of malformations, one patient died three weeks later dues to post operative secondary hemorrhage.

• Brand Name: UNKNOWN LIGASURE INSTRUMENT
• 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: 10072706
• MDR Text Key: 191484027
• Report Number: 1717344-2020-00528
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: EG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN LIGASURE INSTRUMENT
• Device Catalogue Number: UNKNOWN LIGASURE INSTRUMENT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2020
• 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): Death
• Patient Age: 18 YR