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

Catalog Number ACE36E

Device Problems Break (1069); Failure to Cut (2587); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # m9135w.The lot history records were reviewed, and the manufacturing criteria were met prior to the release of this lot.

Event Description

It was reported that during and unknown procedure, an abnormal sound was heard from the scalpel.The tissue could not be cut smoothly.The titanium tip then broke.Used other energy platform to complete the procedure.There was no report on the 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: 8241431
• MDR Text Key: 132970015
• Report Number: 3005075853-2019-15807
• 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: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: ACE36E
• Device Lot Number: M9135W
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1