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

Catalog Number	FCS9
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The batch history records were reviewed and the manufacturing criteria were met prior to the release of this batch.
Event or Problem Description
It was reported that during an unknown procedure, the device was broken during the installation.Changed to another device to complete the procedure.There was no report on patient injury.
Additional Manufacturer Narrative
(b)(4).Investigation summary: the device was received with the handle broken.Due to the returned condition of the device, no functional testing could be performed.In addition, two photos were analyzed.The first image provided by the customer is that of an fsc9 device with the blue torque wrench attached.It is noted that the shrouds are separated.The second image provided by the customer where the fcs9 is disassembled.This issue is typically associated when the user fails to use the provided blue torque wrench and uses the clamp arm handle to tighten the instrument onto the hpblue.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 9CM CURVED SHEAR
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7766039
• Report Number: 3005075853-2018-11918
• Device Sequence Number: 13706138
• Product Code: LFL
• UDI-Device Identifier: 20705036001956
• UDI-Public: 20705036001956
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2018

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: 02/28/2022
• Device Catalogue Number: FCS9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/29/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 09/07/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR AND HANDPIECE