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

Catalog Number	HAR9F
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2018
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 active blade of the device broke.There was no adverse consequence to the patient.
Additional Manufacturer Narrative
(b)(4).Additional information was received: did the broken blade tip fall into the patient? yes.If yes, was the broken blade tip retrieved from the patient? yes.
Additional Manufacturer Narrative
(b)(4).Additional information was received: the device of issue was an har9f, not an fcs9.Catalog is har9f and unique identifier (udi) is (b)(4).
Additional Manufacturer Narrative
(b)(4).Batch # l92a9d.Investigation summary: 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.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.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.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 PLUS ADAPTIVE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8051544
• Report Number: 3005075853-2018-14255
• Device Sequence Number: 1959373
• Product Code: LFL
• UDI-Device Identifier: 10705036001959
• UDI-Public: 10705036001959
• Combination Product (Y/N): N
• PMA/510(K) Number: K132612
• 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,Followup,Followup
• Report Date (Section B): 10/30/2018

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: 08/31/2019
• Device Catalogue Number: HAR9F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 11/11/2018; 01/03/2019; 10/30/2018
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 11/29/2018; 01/04/2019; 01/24/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR AND HANDPIECE