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

Catalog Number	HP054
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the hand piece is not detecting the scissors.The customer has been informed that the hand piece is obsolete.No more information available.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/13/2025.D4 batch #: a9dd61.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: did the patient experience any adverse consequences due to this issue? 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 device was received with the nose cone cracked and the mount was noted to be loose.The device was connected to a gen11 an it was recognized, the reported event of "communications issues" could not be confirmed.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.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.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.

• 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: 22203310
• Report Number: 3005075853-2025-04516
• Device Sequence Number: 7723516
• Product Code: LFL
• UDI-Device Identifier: 20705036002144
• UDI-Public: (01)20705036002144
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR.
• Patient Sex: Unknown