MAUDE Adverse Event Report: MICROLINE SURGICAL INC TLS3 THERMAL LIGATING SHEARS CURVED JAW; ELECTROSURGICAL HANDPIECE, SINGLE-USE

Model Number	132-136D
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There is a wire falling out during the operation.However, the hospital tested it and it's functioning normal (cutting and sealing).Doctor said it may have collateral damage if wire falling out.
Additional Manufacturer Narrative
At this time, msi is awaiting the device back so an investigation can be conducted.Once the investigation is complete and more details are available, a final adverse event report will be submitted.
Additional Manufacturer Narrative
Upon initial examination of the returned 132-136d unit, i could confirm that a wire was exposed outside of the jaws.When the unit was plugged into a working ups, the unit passed the pre-check, variable power check, and high power check per the steps outlined in ifu0033.This failure has been seen before, and a scar was issued to parker ((b)(4)).However, parker conducted an investigation and determined that they built the units with this issue per the work instruction.Additionally, they performed tensile testing on the jumper wire, and determined that the yield strength is much lower than that of the jaw assembly components, which could be why the frayed wire failure mode occurs.At this time, it is not considered a significant health hazard as when the wire fails, it does not detatch and fall into the patient.Therefore, a design change is not necessary at this time.
Event or Problem Description
There is a wire falling out during the operation.However, the hospital tested it and it's functioning normal (cutting and sealing).Doctor said it may have collateral damage if wire falling out.

• Brand Name: TLS3 THERMAL LIGATING SHEARS CURVED JAW
• Common Device Name: ELECTROSURGICAL HANDPIECE, SINGLE-USE
• Manufacturer (Section D): MICROLINE SURGICAL INC; 50 dunham rd suite 1500; beverly MA 01915
• Manufacturer (Section G): PARKER HANNIFIN; blvd bellas artes; lote 12d manzana 22; beverly, tijuana 22444 ; MX 22444
• Manufacturer Contact: scott marchand davis ; 50 dunham rd suite 1500; beverly, MA 01915 ; 9789229810
• MDR Report Key: 21800697
• Report Number: 1223422-2025-00011
• Device Sequence Number: 18220600
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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
• Operator of Device: Health Professional
• Device Model Number: 132-136D
• Device Catalogue Number: 132-136D
• Device Lot Number: 301085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 04/08/2025
• Supplement Report FDA Received Date: 06/18/2025
• 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