MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI FENESTRATED BI POLAR FORCEPS SI; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number DA VINCI SI

Device Problems Defective Device (2588); Noise, Audible (3273)

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

Event Date 09/04/2018

Event Type  No Answer Provided  

Event Description

Instrument "tube" rotation very coarse, grinding, catching.Brand new instrument, not used, not reprocessed.Three of three new instruments out of box defective.

• Brand Name: DA VINCI FENESTRATED BI POLAR FORCEPS SI
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC. ; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 7964955
• MDR Text Key: 124002783
• Report Number: MW5080543
• 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: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DA VINCI SI
• Device Catalogue Number: 420205-14
• Device Lot Number: N10180206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• 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