MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. DA VINCI XI SMALL GRAPTOR-GRASPING RETRACTOR; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number DA VINCI XI

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/30/2017

Event Type  malfunction  

Event Description

Pulley cable broke off robotic instrument during right lobectomy and needed to be retrieved from chest using intra-operative fluoroscopic imaging.Patient was exposed to additional surgical time as well as an additional incision site.Patient was exposed to extended anesthesia time due to additional medical imaging needed to locate and retrieve metal cable piece.Cable piece was retrieved and patient with no permanent harm.Intuitive surgical inc.Failure analysis report 09/2017."failure analysis investigations found broken - distal on the following location instrument pitch cables.".

• Brand Name: DA VINCI XI SMALL GRAPTOR-GRASPING RETRACTOR
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL INC. ; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 6979176
• MDR Text Key: 90411701
• Report Number: MW5072956
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DA VINCI XI
• Device Catalogue Number: 470318-08
• Device Lot Number: S10161221-0017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 82 YR