MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SCALPEL HAND PIECE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	HP054
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 5/28/2025.D4 batch #: y7014h.This is an analysis of an image submitted for evaluation.The image provided by the customer shows a hp054 connector with no apparent damage.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.The handpiece was received with nose cone slightly separate from the mid housing.Due to the condition of the handpiece, no instrument could be attached to the handpiece for testing.Therefore, no functional testing could be performed.The handpiece was disassembled to inspect internal components and all the internal wires were found to be disconnected.The transducer assembly was not held in place due to the gap between nose cone and mid housing.Torqueing of a disposable resulted in the turning of the handpiece transducer assembly.This resulted in the internal wires getting disconnected.This caused and open circuit condition which disabled the instrument.This resulted in the alert screen.No conclusion can be made as to why the nose cone got separated.A manufacturing record evaluation was performed for the finished device batch y7014h, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure the handpiece stopped working.It was tested on other generators and scissors but it did not work.No patient involvement.

• Brand Name: HARMONIC SCALPEL HAND PIECE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 22100468
• Report Number: 3005075853-2025-03983
• Device Sequence Number: 17985169
• Product Code: LFL
• UDI-Device Identifier: 20705036002144
• UDI-Public: (01)20705036002144
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K002906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/28/2025

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 Catalogue Number: HP054
• Device Lot Number: Y7014H032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR.
• Patient Sex: Unknown