MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. INTUITIVE PROGRASP; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Catalog Number 471093

Device Problem Mechanical Jam (2983)

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

Event Type  malfunction  

Event Description

During davinci surgery, the prograsp instrument in arm 2 froze and could not be removed.Davinci it was called, and they walked the surgeon through taking the instrument out manually.The instrument could not be removed through the cannula, so the entire cannula was removed with the prograsp.A new prograsp and cannula were opened to the field.This issue delayed the case about ten minutes.No injury to patient.

• Brand Name: INTUITIVE PROGRASP
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 16504914
• MDR Text Key: 311046209
• Report Number: MW5115554
• 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: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 471093
• Device Lot Number: K11221016 0321
• 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: 43 YR
• Patient Sex: Male
• Patient Weight: 33 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White