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

Catalog Number ACE36E

Device Problems Break (1069); Loose or Intermittent Connection (1371); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p9480t.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 an unknown procedure, solid tone with error code 'tighten assembly' and then the titanium tip broke during the procedure.The broken piece was retrieved by forceps and was discarded.Changed to another device to complete the procedure.There was no report on patient injury.

Manufacturer Narrative

(b)(4) 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.During functional testing on a 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 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 no defects, nc¿s or protocols related to the complaint, were found during the manufacturing process.

• 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
• MDR Report Key: 7700891
• MDR Text Key: 114688220
• Report Number: 3005075853-2018-11371
• 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
• Type of Report: Initial,Followup
• Report Date: 07/04/2018

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: No Information
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: ACE36E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/04/2018
• Initial Date FDA Received: 07/18/2018
• Supplement Dates Manufacturer Received: 07/04/2018
• Supplement Dates FDA Received: 07/27/2018
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE