MEDLINE
Received Jun 2, 2026 · Event occurred May 15, 2026
Report 25359538 · MDR key 25359538
Device
Generic name
Plastic Surgery And Accessories Kit
Manufacturer
Medline Industries, Inc.Model number
DYNJT6861Lot number
25LBB945
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING A SURGICAL CASE IN OR #1 ON LABOR & BIRTH, THE ELECTROSURGICAL UNIT (BOVIE) WAS OBSERVED TO BE SPARKING WHILE IN USE. THE DEVICE WAS IMMEDIATELY REMOVED FROM THE STERILE FIELD AND TAKEN OUT OF SERVICE. A REPLACEMENT BOVIE WAS OBTAINED AND USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. IMMEDIATE ACTIONS TAKEN: BOVIE REMOVED FROM USE AND SEQUESTERED FOR EVALUATION REPLACEMENT EQUIPMENT OBTAINED PROMPTLY PROCEDURE COMPLETED SAFELY WITH NO ADDITIONAL CONCERNS OF NOTE UPON INVESTIGATION STAFF REPORT THIS HAPPENED ONCE BEFORE WITH A CASE LAST WEEK OUTCOME: NO PATIENT HARM OR INJURY OCCURRED. PROCEDURE WAS COMPLETED WITHOUT DELAY OR COMPLICATION AFTER EQUIPMENT REPLACEMENT. BOVIE PEN IN MEDLINE EMERGENCY C-SECTION PACK DYNJT6861, LOT 25LBB945