MAUDE Adverse Event Report: MICROLINE SURGICAL, INC. MICROCEPS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	100-008D
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The microcep was returned with a footswitch and power supply.There was poor continuity between all pins and the heating element ( approximately 500 mohms).The device has significant material degradation of the heating element.The resulting "open circuit" most likely caused a voltage surge that jumped to the atmosphere causing a spark.The complaint is confirmed.
Event or Problem Description
The microlens forceps were being used in a tonsillectomy/adenoidectomy procedure.As the forceps were being used in the child's mouth, a spark/flame was seen at the end of one of the tips.The instrument was immediately removed from the field and disconnected from the cable.There was no harm to the patient.

• Brand Name: MICROCEPS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MICROLINE SURGICAL, INC.; 50 dunham rd; suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL, INC.; 50 dunham rd; suite 1500; beverly MA 01915
• Manufacturer Contact: scott marchand-davis ; 50 dunham rd; suite 1500; beverly, MA 01915
• MDR Report Key: 25650729
• Report Number: 1223422-2026-00007
• Device Sequence Number: 12237897
• Product Code: GEI
• UDI-Device Identifier: 00811099011538
• UDI-Public: 00811099011538
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K000250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 100-008D
• Device Catalogue Number: 100-008D
• Device Lot Number: 602689
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 YR
• Patient Sex: Female
• Patient Weight: 36 KG
• Patient Race: Black Or African American