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

Catalog Number HARH36

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p93c1c.Investigation summary: the analysis results found that the device was received with the tissue pad detached and not returned but with evidence of body fluids and tissue pad material in the groove section of the clamp arm.The device was connected to a test handpiece and tested on a gen11.The device was functional and worked as intended.There were no anomalies noted with the functionality of the device.The instrument was disassembled to inspect the internal components, no evidence was found that could have caused the reported activation issues.Based on the condition of the tissue pad, a probable cause of this damage is that the clamp of the device may have been closed and the instrument activated without tissue present.Care should be taken not to apply pressure between the instrument blade and tissue pad without having tissue between them.Keep the clamp arm open when back cutting or while the blade is active without tissue between the blade and tissue pad to avoid damage to the tissue pad.The resulting damage contributes to the removal of the pad from the clamp arm.The cleaning of the pad, not in accordance with the ifu, can also result in removal of the pad during use.The batch history record was reviewed and no defects, nc¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that the device could not be activated during the procedure.Changed to another one to complete the procedure.There was no report on patient injury.

Manufacturer Narrative

(b)(4).Batch # p93c1c.Corrected data: device investigation submitted under manufacturer report number 3005075853-2018-08041.Evaluation codes submitted under manufacturer report number 3005075853-2018-08041.

• Brand Name: HARMONIC ACE PLUS 7 W ADV HEMOSTASIS
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7394285
• MDR Text Key: 104421179
• Report Number: 3005075853-2018-08864
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 20705036014628
• UDI-Public: 20705036014628
• Combination Product (y/n): N
• PMA/PMN Number: K132612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: HARH36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Date Manufacturer Received: 03/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1