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

Catalog Number	HP054
Medical Device Problem Codes	Failure to Read Input Signal (1581); Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 5/28/2025 d4 batch #: u95d9c investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the hp054 device was received attached to a har device, with the nose cone cracked and the mount was noted to be loose.In addition, coating material of the housing was flaking off.Based on prior investigations, the loose particles on the surface are likely aluminum oxide from the base material.No functional testing could be performed due to the nose cone was extremely cracked and no instrument could be attached to the handpiece.The instrument was disassembled to inspect internal components.The moisture indicator was positive, the acoustic isolator was torn.The transducer assembly was not held in place due to the cracked nose cone, so torquing on the disposable resulted in twisting only the handpiece transducer assembly until the internal wires got disconnected.Due to the cracked nose cone, moisture entered the hand piece mid housing.It is possible that the ingress of moisture affected handpiece functionality.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of the quality process all devices are manufactured, inspected, and released to approved specifications.Although the analysis was unable to determine the exact root cause that lead to crack in the hand piece nose cone.
Event or Problem Description
It was reported that at the beginning of the bariatric surgery, the instrument technician correctly assembled the handpiece, and the generator soon displayed a message asking to replace the instrument.The generator was changed, and when attempting to replace the handpiece, the one that was connected became stuck in the harmonic.Several attempts to remove it were made by the instrument technician and the physician, but they were unsuccessful.Therefore, it was necessary to make a substitution so that the procedure could continue.A clinical engineering staff member was called, and he also could not remove the handpiece.There were no patient consequences.

• 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: 22100538
• Report Number: 3005075853-2025-03984
• Device Sequence Number: 18254730
• 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,Health Professional
• 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: HP054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2025
• 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: 10/22/2020
• 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: HANDPIECE AND GENERATOR.
• Patient Sex: Unknown