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

Catalog Number	FCS17
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.
Event or Problem Description
It was reported that during an open hepatectomy procedure, blade tip was broken off.According to the doctor, the device might have clamped the xiphoid process.But no pieces were left inside the patient.The broken pieces of the blade tip were retrieved and disposed at the operation room.Another device was used to complete the case.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Batch #: p93085.Investigation summary: the device was received with the blade broken off and not returned with the device; in addition the blade was discolored (blue) due to heat generated from contact between the blade and the tissue pad.The device was functionally tested with a gen11.During functional testing an alert screen was displayed.A probable cause of the device stop activating and display an alert screen is blade damage.Probable cause of blade discoloration is applying pressure between the instrument blade and tissue pad without having tissue between them.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.The batch history record was reviewed and no defects, nc¿s or protocols related to the complaint, were found during the manufacturing process.

• 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
• MDR Report Key: 7227702
• Report Number: 3005075853-2018-07637
• Device Sequence Number: 11261089
• Product Code: LFL
• UDI-Device Identifier: 20705036001949
• UDI-Public: 20705036001949
• Combination Product (Y/N): N
• PMA/510(K) Number: K063192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2018

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: 06/30/2022
• Device Catalogue Number: FCS17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1