MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. HARMONIC ACE CURVED SHEARS SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Lot Number M10170529

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2019

Event Type  malfunction  

Event Description

The tip of the harmonic ace curved shears broke off during a robotic case while inside the pt's abdomen. The tip and all other pieces were retrieved and removed from the pt. No pt harm or injury. (b)(6).

• Brand Name: HARMONIC ACE CURVED SHEARS
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 8535829
• MDR Text Key: 142738756
• Report Number: MW5086018
• 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: 02/20/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Lot Number: M10170529
• Was Device Available for Evaluation?: No Answer Provided
• 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?

Type of Device Usage