MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. INTUITIVE SURGICAL DAVINCI XI HOT SHEARS; DA VINCI XI HOT SHEARS

Catalog Number 470179-14

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2018

Event Type  malfunction  

Event Description

Distal shaft on hot shear instrument "cracked" while installing instrument sheath.Did not reach pt.No harm.

• Brand Name: INTUITIVE SURGICAL DAVINCI XI HOT SHEARS
• Type of Device: DA VINCI XI HOT SHEARS
• Manufacturer (Section D): INTUITIVE SURGICAL INC.; 950 kifer road; sunnyvale CA 94086
• MDR Report Key: 7302365
• MDR Text Key: 101286491
• Report Number: MW5075560
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 470179-14
• Device Lot Number: N11170911-0064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• 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