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

Catalog Number ACE36E

Device Problems Flaked (1246); Melted (1385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, two devices from the same lot had the tissue pad flaked and melted.The case was completed by using another like device from different lot.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Only year known, assumed (b)(6) that complaint was reported.Should the information be provided later, a supplemental medwatch will be sent.The analysis results found that the device was returned with the tissue pad detached but with evidence of the tissue pad material in the groove section of the clamp arm.The device was functionally tested on the generator and the max hand control button was not functional.However, the device did activate when it was tested with the footswitch.The device was disassembled to inspect the internal components and corrosion was found at the hand activation domes.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.Cleaning of the pad not in accordance with the ifu can also result in removal of the pad during use.The corrosion in the domes is possibly caused when the device was soaked for re-use or the device being soaked for cleaning before shipment for analysis.The reported failure was confirmed but the root cause cannot be identified because it is unknown when the corrosion occurred.The corrosion would have inhibited electrical contact between the dome and the circuit.Our manufacturing, sterilization, packaging and shipment processes do not introduce corrosion to the device.It is probable that this may have affected the functionality of the hand activation buttons.

• Brand Name: ULTRACISION HARMONIC ACE
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: janice hinsey ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133373009
• MDR Report Key: 3713250
• MDR Text Key: 4266592
• Report Number: 3005075853-2014-02050
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K042777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2018
• Device Catalogue Number: ACE36E
• Other Device ID Number: BATCH K90M2H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR, HANDPIECE