MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HS FOCUS 9CM PLUS ADAPTIVE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	HAR9F
Medical Device Problem Codes	Material Separation (1562); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hernia repair procedure the tip fell off from the device.No other information provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/3/2026.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.The expiration date is currently not available.Therefore, the full udi is currently not available.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.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.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: 3/11/2026.D4 batch #: y70243.Corrected data: d4 udi #.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 determined that the device was returned with the tissue pad melted, and 100% present.The blade was not tip broke off as reported by customer.No suspect diversion were identified.The device was connected to a test handpiece and a gen11, and the device did activate during functional testing.Probable causes of tissue pad damage are applying pressure between the instrument blade and tissue pad without having tissue between them.Avoid activating the blade without tissue between the blade and tissue pad to prevent damage to the tissue pad.Keep the clamp arm open when back cutting or while the blade is active without tissue between the blade and tissue pad to avoid damage to the tissue pad.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch y70243, and no non-conformances were identified.

• Brand Name: HS FOCUS 9CM PLUS ADAPTIVE
• 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: 24250230
• Report Number: 3005075853-2026-01002
• Device Sequence Number: 8233701
• Product Code: LFL
• UDI-Device Identifier: 10705036014669
• UDI-Public: (01)10705036014669(17)290531(10)Y70243
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: HAR9F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HANDPIECE AND GENERATOR
• Patient Sex: Unknown