inforMED
MalfunctionFTN

MEDLINE

Received Jun 2, 2026 · Event occurred May 15, 2026

Report 25359538 · MDR key 25359538

Device

Generic name

Plastic Surgery And Accessories Kit

Model number

DYNJT6861

Lot 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