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

Catalog Number HAR36

Device Problem Replace (1530)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2014

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure the device gets replace instrument.Another device like device was used to complete the case.No patient consequences.

Manufacturer Narrative

(b)(4).Should the information be provided later, a supplemental medwatch will be sent.The device was received with the hand activations contacts bent.The device was connected to a test handpiece with difficulty.During mechanical testing, the rotation knob did not rotate freely.The device was then functionally tested on the gen11 generator.During functional testing, no alert screens were displayed.The device was disassembled to inspect the internal components and no anomalies were noted.The damaged hand activation contacts could cause rotational issues with the device.In addition, it can cause improper torquing of the blade, which could cause the generator to display communication or activation issues and alert screens.To avoid damaging the contacts, it is recommended to assemble the device vertically.Hand switch contacts damaged due to tilted handpiece hitting contact top surface during assembly.

• Brand Name: HARMONIC ACE ATT
• 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4177938
• MDR Text Key: 18290930
• Report Number: 3005075853-2014-07135
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K120729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HAR36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE