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

Catalog Number	HAR17F
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an unknown procedure, the blade was broken when the device was used on muscle.No pieces were left inside the patient.Gen11 was used.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: 2/22/2024 d4 batch #: x9683j.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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.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: 3/25/2024.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 distal tip of the blade broken off and it was returned with the device.The remaining blade portion was scratched and with evidence of contact with metal in or out of the operative field.During functional testing on gen11, an alert screen was displayed.A probable cause of the device stop activating and displaying an alert screen is blade damage.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Probable causes of blade damage, including breakage, are external contact during pre-op or general use, blade contact with other devices, staples, or clips during the procedure, or using any means other than the blade wrench to attach or detach the blade.Once minor blade damage has occurred, subsequent activations may increase damage severity and can result in not passing the pre-run test followed by an alert screen, such as ¿tighten assembly¿, ¿blade error detected¿ or "relaxed pressure on blade" followed by a ¿replace instrument¿ screen later in the procedure, and continued usage can result in a broken blade.

• 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 18758807
• Report Number: 3005075853-2024-01540
• Device Sequence Number: 20410339
• Product Code: LFL
• UDI-Device Identifier: 30705036014731
• UDI-Public: 10705036014737
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 02/22/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR AND HANDPIECE
• Patient Sex: Unknown