MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. DA VINCI XI/X FENESTRATED BIPOLAR FORCEPS; SQYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number N10160523-0001

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2016

Event Type  malfunction  

Event Description

Insulation material used on this device broke off.Energy cable broke due to insulation failure allowing jaws to open past intended limit.No patient harm.

• Brand Name: DA VINCI XI/X FENESTRATED BIPOLAR FORCEPS
• Type of Device: SQYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL INC. ; 950 kifer rd. ; sunnyvale CA 94086
• MDR Report Key: 6979178
• MDR Text Key: 90423459
• Report Number: MW5072958
• 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: N10160523-0001
• Device Catalogue Number: 470205-13
• Device Lot Number: N10160523
• 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: 60 YR