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

Model Number	FCS17
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: did the patient experience any adverse consequences due to this issue? 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.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.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 whipple procedure the blade broke.The surgery was delayed 20 minutes but it was completed successfully.
Additional Manufacturer Narrative
(b)(4) date sent: 6/14/2021 additional information was requested and the following was obtained: did the patient experience any adverse consequences due to this issue? -no product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.

• 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: 11701425
• Report Number: 3005075853-2021-02149
• Device Sequence Number: 19747654
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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 Model Number: FCS17
• Device Catalogue Number: FCS17
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 05/29/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 06/14/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR AND HANDPIECE.; GENERATOR AND HANDPIECE.