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

Model Number CA VINCI SI

Device Problems Display or Visual Feedback Problem (1184); Defective Device (2588); Protective Measures Problem (3015)

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

Event Date 09/25/2018

Event Type  No Answer Provided  

Event Description

Instrument "tube" rotation very coarse, grinding, catching.Brand new instrument, not used, not reprocessed.Two of three new instruments out of box defective.(two of three completely different si instruments displaying the same "tube" rotation issue).

• Brand Name: DA VINCI SI CADIERE FORCEPS
• Type of Device: SYSTEM SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL INC. ; 1266 kifer rd; sunnyvale CA 94086
• MDR Report Key: 7964933
• MDR Text Key: 123851019
• Report Number: MW5080540
• 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: No Information
• Device Model Number: CA VINCI SI
• Device Catalogue Number: 420049-09
• Device Lot Number: N10180207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• 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