da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
Recall
- Recall Number
- Z-0927-2020
- Event Number
- 84335
- Firm
- Intuitive Surgical, Inc.
- FEI Number
- 3001675293
- Product Code
- NAY
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- July 26, 2019
- Terminated
- August 10, 2022
- Address
- 1266 Kifer Rd, Bldg 101, Sunnyvale, CA, 94086-5304
Description
da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, you may experience either vision loss or non-recoverable errors 307 or 319, preventing further use of the system.
On July 26, 2019, Intuitive sent out a "Urgent Medical Device Correction" letter to affected consignees via FedEx, the Intuitive Customer Portal, and via Email. In addition, to informing their consignees about the recall, the letter also asked consignees to take the following actions: 1. If necessary, please follow the System Troubleshooting section in your specific system user manual for guidance on how to proceed in the scenario where vision loss or a non-recoverable error is experienced, including contacting Intuitive Technical Support. In addition: 2. Forward this letter to your Risk Manager, OR Director, Purchasing, Biomedical Engineering staff, and other members of your medical staff who perform da Vinci procedures. 3. Inform affected personnel when corrective action has been completed. 4. If available, please log into the da Vinci Online Community Field Action resource to read or complete any requested actions related to this issue, at this link: https://www.davincisurgerycommunity.com/ 5. In the event the da Vinci online resource cannot be used, complete the attached Acknowledgement Form and return it via fax or email to Intuitive as instructed on the form. 6. Please retain a copy of this letter and the Acknowledgement Form for your files. 7. An Intuitive representative will contact customers with affected da Vinci Xi, X, and SP Surgical Systems to schedule a site visit and replace the necessary component. 8. If you need further information or support concerning this Medical Device Notification , please contact your Clinical Sales Representative or contact Intuitive Customer Service at the numbers listed below: " North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: [email protected]. " Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or [email protected] " South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) " Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 P
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4 Surgical Systems