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

Catalog Number	HP054
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during the laparoscopic procedure, the root of the handpiece was peeled off, and the internal part was visible.The handpiece could be used.No pieces were fell into the patient.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/10/2025 d4 batch #: unknown d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/15/2025.This is an analysis of an image submitted for evaluation.The image provided by the customer shows a harhpgr instead of an hp054 with the cable insulation damage at the end cap area.Possible causes that may have contributed to the cable damage include the cable being ran over, or getting tangled by the cart wheels.Based on the photo, the reported event was confirmed.As part of the quality process all devices are manufactured, inspected, and released to approved specifications.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.

• Brand Name: HARMONIC SCALPEL HAND PIECE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 22176272
• Report Number: 3005075853-2025-04360
• Device Sequence Number: 7818650
• Product Code: LFL
• UDI-Device Identifier: 20705036002144
• UDI-Public: 20705036002144
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 06/10/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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