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

Model Number	132-134D
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The device had intermittent power, the handpiece would work maybe once and then stop.
Additional Manufacturer Narrative
At this time, an investigation is being conducted with devices from the same lot as the device used during the event.Once an investigation report is available, a final report will be submitted with more information.
Additional Manufacturer Narrative
Despite requests made to the manufacturer, the specific device associated with the complaint was not returned.Although 11 units from the same lot were received in sealed pouches, the defective unit could not be evaluated.As a result, the reported issue could not be confirmed.
Event or Problem Description
The device had intermittent power, the handpiece would work maybe once and then stop.

• Brand Name: TLS3 THERMAL LIGATING SHEARS CURVED JAW
• Common Device Name: ELECTROSURGICAL HANDPIECE, SINGLE-USE
• Manufacturer (Section D): MICROLIONE SURGICAL; 50 dunham rd; beverly MA 01915
• Manufacturer (Section G): PARKER HANNIFIN; blvd bellas artes; lote 12d manzana 22; lote 12d manzana 22, beverly, tijuana 22444 ; MX 22444
• Manufacturer Contact: scott marchand davis ; 50 dunham rd; beverly, MA 01915 ; 9789229810
• MDR Report Key: 22116280
• Report Number: 1223422-2025-00014
• Device Sequence Number: 7156937
• Product Code: GEI
• UDI-Device Identifier: 00811099011460
• UDI-Public: 00811099011460
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K122086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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: 132-134D
• Device Catalogue Number: 132-134D
• Device Lot Number: 403534
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 105 KG