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

Model Number 470230

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2023

Event Type  malfunction  

Event Description

Davinci endowrist large clip applier was unable to be removed from robotic arm.Davinci technical support was called with instructions provided to pry the instrument from the robotic arm.The instrument was successfully removed from the robotic arm, and a "like" device was applied and utilized without incident.(lives of instrument used: 22/100).

• Brand Name: ENDOWRIST LARGE CLIP APPLIER
• Type of Device: SYSTEM SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 16336369
• MDR Text Key: 309285719
• Report Number: MW5114797
• 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: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470230
• Device Catalogue Number: 470230
• Device Lot Number: N101804110136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White