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

Catalog Number HARH36

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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, the device was working well during the procedure but half way through the surgeon noticed that the protective white pad had come off.The pad was retrieved from the patient.This did not allow the device to function correctly; therefore, they stopped using the device.It is unknown how the procedure was completed.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).Batch # p91r59 the device was returned with the tissue pad damaged, melted, not all present and a piece was not returned.In addition, the tissue pad was attached to the clamp arm and not detached as reported by the customer.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.Probable causes of tissue pad damage are applying pressure between the instrument blade and tissue pad without having tissue between them.Prolonged usage of advanced hemostasis mode may cause tissue pad damage.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 batch history record was reviewed and there were no defects, protocols or ncr(s) found during the manufacturing process related to this complaint.

• 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: 6755111
• MDR Text Key: 81568836
• Report Number: 3005075853-2017-03908
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: HARH36
• Device Lot Number: P91R59
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1