MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE 36CM W ERG HANDLE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number ACE36E

Device Problem Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p9480u.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 had 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 a gen11, an alert screen was displayed.A probable cause for the device to stop activating and for the gen11 to display an alert screen is blade damage.Due to the returned condition of the device, the reported event of "tissue effect issues", could not be confirmed.Probable causes of blade damage, including breakage, are external contact during pre-op or general use, blade contact with other devices, contact with 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 activation may increase the severity of the blade damage.This, in turn, can result in the device failing the pre-run test with the generator and displaying an alert screen.The alert screens that can result may include ¿tighten assembly,¿ ¿blade error detected,¿ or "relax pressure on blade," followed by a ¿replace instrument¿ screen later in the procedure.Continued usage of the damaged blade can result in a broken blade.The batch history record was reviewed and there were no defects, protocols or ncr(s) found during the manufacturing process related to this complaint.

Event Description

It was reported that during and unknown procedure, the scalpel hard was to cut and coagulate.Changed to another one to complete the procedure.There was no report on patient injury.

• Brand Name: HARMONIC ACE 36CM W ERG HANDLE
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8291474
• MDR Text Key: 134597866
• Report Number: 3005075853-2019-16292
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036000938
• UDI-Public: 10705036000938
• Combination Product (y/n): N
• PMA/PMN Number: K042777
• 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: 01/19/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: ACE36E
• Device Lot Number: P9480U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2019
• Initial Date FDA Received: 01/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE