MAUDE Adverse Event Report: MICROLINE SURGICAL TLS3 THERMAL LIGATING SHEARS CURVED JAW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	132-136D
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Power not working correctly.Power level jumps randomly.
Additional Manufacturer Narrative
Device has not yet been returned.Investigation pending.
Additional Manufacturer Narrative
The thermal ligating shears were received, decontaminated, and visually inspected.For the two units from lot 305080 the jaws appear to be burned with insulation missing on the back of the jaws.There was also a pin loose.The complaint is confirmed.
Event or Problem Description
Power not working correctly.Power level jumps randomly.

• Brand Name: TLS3 THERMAL LIGATING SHEARS CURVED JAW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MICROLINE SURGICAL; 50 dunham rd; suite 1500; beverly MA 01915
• Manufacturer Contact: scott marchand-davis ; 50 dunham rd; suite 1500; beverly, MA 01915
• MDR Report Key: 23469203
• Report Number: 1223422-2025-00036
• Device Sequence Number: 8890973
• Product Code: GEI
• UDI-Device Identifier: 00811099011484
• UDI-Public: 00811099011484
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K062257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 132-136D
• Device Catalogue Number: 132-136D
• Device Lot Number: 502634
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown