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	09/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # p91r2y.A manufacturing record evaluation was performed for the finished device lot and batch number and no non-conformances were identified.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.Additional information received: are there any plans to locate the piece? unknown.Was there any change in the patient care as a result of this event? unknown.What is the current patient status?" unknown.
Event or Problem Description
It was reported that during an unknown open procedure, the titanium tip was broken.The broken piece was 1.5-2mm and it's location was not confirmed.The blade tip was black and charred and the operator had not heard any harsh sound.The doctor "searched for it in the view and takes a c-arm x-ray machine." changed to another one to complete surgery.The patient is stable for now.
Additional Manufacturer Narrative
(b)(4).Batch # p91r2y.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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances 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
• MDR Report Key: 9137644
• Report Number: 3005075853-2019-22474
• Device Sequence Number: 16798340
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2019

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: FCS9
• Device Lot Number: P4RR8W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR AND HANDPIECE