MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. LARGE CLIP APPLIER; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number VER: 12

Device Problem Failure to Sense (1559)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Clip applier was inserted onto robot arm and it was "not detected".Fda safety report id # (b)(4).

• Brand Name: LARGE CLIP APPLIER
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 13011159
• MDR Text Key: 282359411
• Report Number: MW5106046
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VER: 12
• Device Lot Number: N10190504 0054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female