MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. DA VINCI XI XI FENESTRATED BI POLAR FORCEPS

Model Number DA VINCI XI

Device Problems Material Discolored (1170); Stretched (1601)

Patient Problem No Patient Involvement (2645)

Event Date 04/17/2018

Event Type  malfunction  

Event Description

Da vinci fenestrated bi polar forceps showing "stretched" black energy cable on the distal end of instrument before delivery to sterile field for pt use. Instrument was removed and processed for return to mfr.

• Brand Name: DA VINCI XI
• Type of Device: XI FENESTRATED BI POLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL INC.; oakland CA 94609
• MDR Report Key: 7446815
• MDR Text Key: 106250956
• Report Number: MW5076603
• 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: 04/18/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: DA VINCI XI
• Device Catalogue Number: 470205
• Device Lot Number: N10171121-0013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage