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 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p9439r.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 for the device to stop activating and the gen11 to display an alert screen is blade damage.Due to the condition of the device, no functional testing could be performed to evaluate the incident reported.The device will stop activating when the blade becomes damaged.The reported complaint was confirmed.Once minor blade damage has occurred, subsequent activations may increase the severity of the blade damage.This in turn can result in failing the pre-run test with the generator and displaying an alert screen.These alert screens that can result are such as ¿tighten assembly¿, ¿blade error detected¿ or "relaxed pressure on blade" followed by a ¿replace instrument¿ screen later in the procedure.Continued usage of the damage blade can result in a broken blade.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that during an unknown procedure, the scalpel was hard to cut during the procedure.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: 7646301
• MDR Text Key: 112846809
• Report Number: 3005075853-2018-11000
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 20705036000935
• UDI-Public: 20705036000935
• 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: 06/14/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: ACE36E
• Device Lot Number: P9439R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1