| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00135-1 |
| Product Name/Description |
Intuitive Harmonic ACE Instruments (used with the da Vinci Standard, S, and Si Surgical Systems)
5mm Harmonic ACE instruments
Product Codes: INS-400274, INS-400275
8mm Harmonic ACE instruments
Product Codes: INS-420274, INS-420275
Harmonic ACE Curved Shears Disposable Insert
Product Code: INS-400272
ARTG number: 132451 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Intuitive Surgical has found that the Harmonic ACE IFU contains incorrect instructions in regard to the proper use of the Instrument Release Kit (IRK) (or “emergency grip release Allen wrench”). The Harmonic ACE IFU instructs the user to turn the IRK counter-clockwise. The correct instruction is to turn the IRK clockwise. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are asked to discard the current Harmonic Ace IFUs (IFU Part number: 550635-01, 550635-02 550635-03, 550635-04) that they may have. Users are asked to refer to either the Instruments and Accessories User Manual, the Quick Reference Guide that is physically attached to the system, and the metal instruction card that is attached to the IRK provide step-by-step instructions on how to properly perform the emergency grip release.Please also note that the Instruments and Accessories User Manual contain other warnings not listed in the IFU or have information listed in more detail. This action has been closed-out on 15/07/2016. |
| Contact Information |
1800 338 423 - Device Technologies Australia Pty Ltd |