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

Model Number	FCS17
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the cutting & coagulation was not working.The surgery was delayed by 15 minutes.The device was replaced.The procedure was completed successfully.
Additional Manufacturer Narrative
(b)(4).Batch #: r4029j.Additional information was requested and the following was obtained: did the patient experience any adverse consequences due to this issue?-no investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.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.This blade tip portion may have broken off of the device during transport to our analysis site.During functional testing on gen11 an alert screen was displayed.A probable cause of the device stop activating and display 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.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: HS FOCUS 17 CM CURVED SHEAR
• 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: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 12897023
• Report Number: 3005075853-2021-07239
• Device Sequence Number: 4024559
• Product Code: LFL
• UDI-Device Identifier: 10705036001942
• UDI-Public: 10705036001942
• Combination Product (Y/N): N
• PMA/510(K) Number: K063192
• 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): 11/30/2021

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: 12/31/2022
• Device Model Number: FCS17
• Device Catalogue Number: FCS17
• Device Lot Number: R4029J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2018
• 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