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	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hepatectomy the surgery begins and after 10 minutes of use the active blade breaks.The procedure was delayed 10 minutes.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/15/2024.D4 batch #: unknown.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 is pending for the finished device lot number 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: 5/23/2024.An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device lot number 553c88, and no non-conformances were identified.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/7/2025.Corrected data: d4 udi #.This is an analysis of an image submitted for evaluation.The image provided by the customer shows a har17f device with the blade tip broken inside tube.Based on the photo, the reported event was confirmed.However, no conclusion could be reached as to how this issue occurred through photo analysis.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.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/9/2025.This is an analysis of an image submitted for evaluation.The image provided by the customer shows a har17f device with the blade tip broken inside tube.Based on the photo, the reported event was confirmed.However, no conclusion could be reached as to how this issue occurred through photo analysis.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 lot number 553c88, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/7/2025 d4 batch #: a9de7y 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 not returned.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 for the device to stop activating and the gen11 to display an alert screen is blade damage.The device was disassembled to verify the internal components and no anomalies were found.The image provided by the customer shows a har17f device with the blade tip broken inside tube.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 the severity of the blade damage.This in turn can result in activation issues such as failing the pre-run test with the generator and displaying an alert screen.These alert screens that can result are such as ¿tighten assembly¿, ¿blade error detected¿ or "relaxed pressure on blade" followed by a ¿replace instrument¿ screen later in the procedure.Continued usage of the damage blade can result in a broken blade.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 a9de7y, and no non-conformances were identified.

• 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: 19110758
• Report Number: 3005075853-2024-02927
• Device Sequence Number: 12689479
• Product Code: LFL
• UDI-Device Identifier: 10705036014737
• UDI-Public: (01)10705036014737(17)280630(10)553C88
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/15/2024

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
• Device Lot Number: 553C88
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: Not provided; 05/06/2025; 05/07/2025; 08/06/2025
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 05/23/2024; 05/07/2025; 05/09/2025; 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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: Female