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	01/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We have 10 units form the same lot nr.406558.Client complaints the they had to press harder than usual and after 3 to 4 beeps the power cut out and they had to reactivate.This happened only with entceps lot: 406558, the same lot as we already had the same complaint for with regards to mfr report#: 1223422-2025-00001.
Additional Manufacturer Narrative
At this time, microline surgical is awaiting the affected device back from our distributor in the uae, life medical equipment.Once the device is received, an investigation will be completed and a final adverse event report will be submitted.

• 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: 21462808
• Report Number: 1223422-2025-00004
• Device Sequence Number: 19712585
• 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): 02/25/2025

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: 406558
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 02/25/2025
• 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