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

Model Number	110-005D
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No investigation could be conducted as the device that was involved in the incident was discarded by the hospital.
Event or Problem Description
Ent not working properly.Sealing function not working continously.They have discarded the forceps after usage.Anesthesia time was extended and another set from a different lot was used successfully.

• 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: 21218057
• Report Number: 1223422-2025-00001
• Device Sequence Number: 18339552
• Product Code: GEI
• UDI-Device Identifier: 00811099011545
• UDI-Public: 00811099011545
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2025

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: 110-005D
• Device Catalogue Number: 110-005D
• Device Lot Number: 406558
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 01/23/2025
• 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