| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00114-1 |
| Product Name/Description |
5mm and 8mm Harmonic ACE Instruments IFU (for use with 5mm Harmonic ACE instruments (PNs 400274 and 400275)
8mm Harmonic ACE instruments (PNs 420274 and 420275) and
Harmonic ACE Curved Shears Disposable Insert (PN 400272)
used with the da Vinci Standard, S, and Si Surgical Systems.
Model Numbers: 550635-01; 550635-02; 550635-03; 550635-04 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
17/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Device Technologies Australia is informing the customers: Intuitive Surgical has found that the Harmonic ACE IFU used with the da Vinci Standard, S, and Si Surgical Systems, contains incorrect instructions in regard to the proper use of the inInstrument Release Kit (IRK) (or “emergency grip release Allen wrench”). The Harmonic ACE IFU instructs the user to turn the IRK counterclockwise. The correct instruction is to turn the IRK clockwise. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies Australia (DTA) is requesting the users to discard the currentHarmonic ACE IFUs and to follow the instructions from the Instrument and Accessories User Manual, section 9.1. Introduction, paragraph General Precautions and Warnings; that is attached to the system. |
| Contact Information |
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