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

Catalog Number	HAR17F
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 3/22/2024.D4 batch #: t94k7k.Additional information was requested and the following was obtained: did the patient experience any adverse consequences due to this issue? the patient didn¿t have any adverse consequences since the surgeon used a new probe and handpiece then & there only 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 damaged, melted, not all present, and the missing portion was not returned.The remaining tissue pad was properly attached to the clamp.The device was connected to a test handpiece and a gen11 and the device did activate during functional testing.The device was analyzed, and it was determined that it was possibly used in more than one procedure, based on generator data.The device is intended and labeled for single patient use.If the device is connected to multiple generators, an alert screen will be displayed indicating ¿adaptive tissue technology features are not available in this device¿.The device was disassembled to verify the condition of the internal components and no anomalies were found.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.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 the 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 t94k7k, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device lot 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.
Event or Problem Description
It was reported that during a general surgery the device didn't work and got stuck in hpblue.It couldn't be disengaged from the handpiece.The doctor had to use a new handpiece and har17f.The stuck har17f got disengaged after multiple efforts.The procedure was delayed 10 minutes but was completed successfully.

• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 18961028
• Report Number: 3005075853-2024-02329
• Device Sequence Number: 8030750
• Product Code: LFL
• UDI-Device Identifier: 10705036014737
• UDI-Public: 10705036014737
• 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): 03/22/2024

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 Expiration Date: 08/31/2024
• Device Catalogue Number: HAR17F
• Device Lot Number: A9CD9K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2019
• 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: HANDPIECE AND GENERATOR.
• Patient Sex: Unknown