MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE + 7; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARH36

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Loose or Intermittent Connection (1371)

Event Date 10/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) date sent: 12/9/2016.Batch #(b)(4).Additional information received: the pad just came off.Before use.Before the surgeon could activate the device.He did not activate the device.Additional information requested: could you please advised: was the tissue pad separated from the metal jaw while in the sterile package or did the tissue pad separate from the metal jaw after removal from the package? was the tissue pad cleaned prior to use, with something like a 4 x 4 pad? did the tissue pad get snagged on a cleaning pad? did this issue occur at the very first use of this device? did the issue occur prior to or after the pre-run testing on the generator? was the harh36 re-used? 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 hand piece and a gen11 and the device did activate during functional testing.The device was disassembled to inspect the internal components and no anomalies were found.Based on the condition of the tissue pad, a probable cause for 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 records were reviewed and the manufacturing criteria were met prior to the release of the batch.

Event Description

It was reported that during a nephrectomy procedure, pre-operative, the silicone white pad came loose.It fell before use on the patient.Another like device was used to complete the procedure.There were no adverse consequences for the patient reported.

• Brand Name: HARMONIC ACE + 7
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 6157842
• MDR Text Key: 241268963
• Report Number: 3005075853-2016-06934
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K132612
• 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: 11/18/2016

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: 06/22/2021
• Device Catalogue Number: HARH36
• Device Lot Number: N9259X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1