MAUDE Adverse Event Report: MICROLINE SURGICAL INC ENTCEPS; ELECTROSURGICAL HANDPIECE, SINGLE-USE

Model Number	110-005D
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, microline surgical is awaiting the device back so an investigation can be done.Once the investigation has been completed and more information is available, a final adverse event report will be submitted.
Event or Problem Description
During a tonsillectomy, the device failed cutting during procedure.

• Brand Name: ENTCEPS
• 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: 21645638
• Report Number: 1223422-2025-00007
• Device Sequence Number: 12678023
• Product Code: GEI
• UDI-Device Identifier: 00811099011545
• UDI-Public: 00811099011545
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K001262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/19/2025

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: 110-005D
• Device Catalogue Number: 110-005D
• Device Lot Number: 405545
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 03/19/2025
• 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
• Patient Sex: Unknown