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

Model Number E2516HNSB

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 05/24/2023

Event Type  Injury  

Event Description

Bovie handpiece was laying on patient when surgical tech plugged into generator.Bovie turned on by itself and burned patient's skin requiring wound to be excised and closed with a suture.Tech had acted quickly and pulled it off patient, preventing a more severe injury.Manufacturer response for bovie cautery pencil, covidien (per site reporter).Awaiting response.

• Brand Name: VALLEYLAB
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 17423764
• MDR Text Key: 320050228
• Report Number: 17423764
• Device Sequence Number: 1
• Product Code: GEI
• 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: 06/06/2023

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 Model Number: E2516HNSB
• Device Lot Number: 893231
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 23725 DA
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Race: White