MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. INTUITIVE SURGICAL ROBOTIC EQUIPMENT DA VINCI ROBOTIC HOOK; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Lot Number N111810040097

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2019

Event Type  malfunction  

Event Description

Patient in surgery for robotic assisted cholecystectomy.Intuitive da vinci equipment used for surgery.Hook broke.No missing pieces noted upon removal of equipment.No harm to the patient.

• Brand Name: INTUITIVE SURGICAL ROBOTIC EQUIPMENT DA VINCI ROBOTIC HOOK
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 8343866
• MDR Text Key: 137120762
• Report Number: MW5084132
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: N111810040097
• Was Device Available for Evaluation?: Yes
• 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
• Patient Age: 61 YR
• Patient Weight: 79