MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36; INSTRUMENT, ULTRASONIC SURGICAL

Model Number HARH36

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #unk.Investigation summary: the device was returned with the distal tip of the blade broken off and not returned.The remaining blade portion was scratched with evidence of contact with metal in or out of the operative field.This blade tip portion may have broken off of the device during transport to our analysis site.During functional testing on gen11, an alert screen was displayed.A probable cause for the device to stop activating and the gen11 to display an alert screen is blade damage.To avoid "handle component issues," it is recommended to assemble the device vertically.If the hand piece is inadvertently tilted during the assembly with the instrument, the hand activation contacts can be damaged and could cause an improperly connection between the hand piece and the device.This condition could result in activation issues or alert screens, however, this could not be seen during our analysis.The device was disassembled to inspect the internal components and no anomalies were found.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/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 the severity of the blade damage.This in turn can result in activation issues such as failing the pre-run test with the generator and displaying an alert screen.These alert screens that can result include ¿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.

Event Description

It was reported that during an unknown procedure, the rotation knob would not work normally.Changed to another device to complete surgery.There was no patient consequence reported.No additional information can be provided.

• Brand Name: HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10081106
• MDR Text Key: 192015882
• Report Number: 3005075853-2020-02706
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036014621
• UDI-Public: 10705036014621
• Combination Product (y/n): N
• PMA/PMN Number: K132612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HARH36
• Device Catalogue Number: HARH36
• Device Lot Number: T94L55
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Date Manufacturer Received: 04/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1