MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HS SYNERGY COMBO HOOK BLADE; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	SNGHK2
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Additional information was requested and the following was received: did the patient experience any adverse consequences due to this issue? no.
Event or Problem Description
It was reported that during an unknown procedure, the device blade was broken.There were no patient consequences.No additional information is available at this time.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/26/2020.D4: batch #t93e0x.Investigation summary the device was returned with the blade scratched and cracked.In addition, the blade was not broken off as reported.The device was functionally tested with a generator.During functional testing on gen11 an alert screen was displayed.A probable cause of an alert screen is blade damage.The device will stop activating and display an alert screen when the blade becomes damaged.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.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 blade damage severity and result in alert screens, such as ¿tighten assembly,¿ ¿blade error detected¿ or "relax pressure on blade," followed by a ¿replace instrument¿ screen later in the procedure.Continued usage can result in a broken blade.

• Brand Name: HS SYNERGY COMBO HOOK BLADE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9781091
• Report Number: 3005075853-2020-01389
• Device Sequence Number: 526656
• Product Code: LFL
• UDI-Device Identifier: 10705036013815
• UDI-Public: 10705036013815
• Combination Product (Y/N): N
• PMA/510(K) Number: SNGHK2
• 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): 02/06/2020

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: 04/30/2024
• Device Model Number: SNGHK2
• Device Catalogue Number: SNGHK2
• Device Lot Number: T40L75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 03/26/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR AND HANPIECE