MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HS FOCUS 17CM PLUS ADAPTIVE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	HAR17F
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 9/8/2025 d4 batch #: x95843.Investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.The device was returned and was noted a length on the blade, is shorter than usual and not parallel to the clamp arm.The device was connected to a test handpiece and tested on a gen11.The device was nonfunctional when the max or min hand activation buttons were depressed.The device was disassembled to verify the condition of the internal components, and it was noted that the retention pin was not aligned correctly that is why the blade noted to be shorter, positioning itself in another slot, which is damaged and making not contact with the hand activation resulting that cannot activate the device.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Our manufacturing process has been identified to be the possible cause of the misassembled blade.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through the quality system.A manufacturing record evaluation was performed for the finished device batch x95843, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.
Event or Problem Description
It was reported that during a colectomy, after open product from packaging and use it, the product was not working.There were no patient consequences.

• Brand Name: HS FOCUS 17CM 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: 22994970
• Report Number: 3005075853-2025-07115
• Device Sequence Number: 13166731
• Product Code: LFL
• UDI-Device Identifier: 10705036014737
• UDI-Public: (01)10705036014737(17)270531(10)878A10
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/08/2025

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: HAR17F
• Device Lot Number: 878A10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2022
• 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: GENERATOR AND HANDPIECE
• Patient Sex: Unknown