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

Catalog Number	HAR9F
Medical Device Problem Code	Insufficient Device Problem Information (3190)
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: 7/23/2025.D4 batch #: a9df5v.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 blade discolored (blue) due to heat generated from contact between the blade and tissue pad.However, the blade was not cracked.The device was connected to a test handpiece and tested on a gen11.The device did activate during functional testing.During analyzed, it was determined that the device was connected to more than one generator.Adaptive tissue technology devices are supplied sterile, single patient use instruments.Using the device on more than one generator is potentially associated with device re-use.Multiple patient use may compromise the device integrity or create a risk of contamination that, may result in patient injury or illness.If the device is connected to a different generator an alert screen will be displayed indicating ¿adaptive tissue technology features are not available in this device¿.Possible causes of the blade 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 blade and tissue pad.Due to the multiple generator usage, which is evidence of possible reuse, we are unable to determine how this condition impacted the performance of the device and therefore cannot conclude root cause.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 a9df5v, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure the device was not working.

• 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 ; * 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: 22579018
• Report Number: 3005075853-2025-05824
• Device Sequence Number: 9237790
• Product Code: LFL
• UDI-Device Identifier: 10705036014669
• UDI-Public: (01)10705036014669(17)280630(10)A9DF5V
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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: HAR9F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2023
• 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