MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number E2100

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

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during a pacemaker implantation procedure, on the first cut the drape (sheet) that covered the patient began to burn, then the drape that separates the operating field from the anesthesia station and also the patient's cap began to burn.A non medtronic neutral electrode had been located on patient`s lower backs, monopolar pen has been used on patient`s leg.Patient suffered 2nd - 3rd degree burns (5% of the body) on the back, shoulder, arm, neck and ear.Thus leading to patient's 7 days extended hospitalization, re-operation/additional surgery and being relocated to the care of the burn treatment center.The treatment was still conservative (bandages of the affected areas).Any other intervention will be decided after 10 days from the accident.

• Brand Name: VALLEYLAB
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 11088583
• MDR Text Key: 224095636
• Report Number: 3006451981-2020-00198
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00884524001590
• UDI-Public: 0884524001590
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K942183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E2100
• Device Catalogue Number: E2100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/29/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR