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

Model Number XI

Device Problems Separation Failure (2547); Mechanical Jam (2983)

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

Event Date 02/27/2023

Event Type  malfunction  

Event Description

During a robotic chole, the prograsp was unable to be removed from the robotic trocar.The surgeon ended up removing the trocar with the prograsp still inserted as the trocar and instrument could not be separated.The prograsp was sent down to spd still in the trocar for spd to separate them.There were no deviations in care and no harm to patient caused, and the procedure was completed as planned.

• Brand Name: DA VINCI PROGRASP FORCEPS
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 16537259
• MDR Text Key: 311319585
• Report Number: MW5115723
• 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: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XI
• Device Catalogue Number: 471093 VER 11
• Device Lot Number: K11220614-0145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2023
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 54 KG