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 Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 4/4/2024 d4 batch #: x95c3j additional information was requested and the following was obtained: did the generator display any error messages and if so what were they? reactivation of the two switch ( foot switch ) later its sensor of screen stopped working.Did the device pass the pre-test? no its sensor was not working had the device been working and then stopped? yes it was showing error from many days later its sensor only stopped working.Did the patient experience any adverse consequences due to this issue? unknown 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 handle broken and the piece was returned.The device was connected to a test handpiece and tested on a gen11.  the device was functional when the max or min hand activation buttons were pressed.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 internal components and no anomalies were noted.  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 x95c3j, and no non-conformances 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 an unknown procedure the device broken at the time of surgery.

• 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: 19043652
• Report Number: 3005075853-2024-02618
• Device Sequence Number: 12601359
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2024

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
• Date Returned to Manufacturer: 03/21/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2022
• 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