MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HS FOCUS 9CM CURVED SHEAR; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	FCS9
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: p92187.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.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 white tissue pad completely fell off.The fallen piece was retrieved by forceps and was disposed.Changed to another device to complete the surgery.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4) date sent: 7/5/2022 d4 batch #: p92187 investigation summary the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the fcs9 device was received with the tissue pad detached and not returned but with evidence of body fluids and tissue pad material in the groove section of the clamp arm.The device was connected to a test handpiece and a gen11 and the device did activate during functional testing.Based on the condition of the tissue pad, a probable cause for this damage is that the clamp of the device may have been closed and the instrument activated without tissue present.Care should be taken not to apply pressure between the instrument blade and tissue pad without having tissue between them.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.The resulting damage contributes to the removal of the pad from the clamp arm.The cleaning of the pad, not in accordance with the ifu, can also result in the removal of the pad during use.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.

• Brand Name: HS FOCUS 9CM CURVED SHEAR
• 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: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 13905293
• Report Number: 3005075853-2022-01824
• Device Sequence Number: 17160002
• Product Code: LFL
• UDI-Device Identifier: 10705036001959
• UDI-Public: 10705036001959
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 03/25/2022

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: 03/31/2022
• Device Model Number: FCS9
• Device Catalogue Number: FCS9
• 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: 03/07/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR AND HANDPIECE
• Patient Sex: Unknown