MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; FORCE BIPOLAR

Model Number 471405-06

Device Problem Difficult to Remove (1528)

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

Event Date 03/25/2024

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted general surgical umbilical hernia surgical procedure, robotic coordinator reported mid-procedure they were not able to remove the force bipolar instrument from the cannula.The robotics coordinator stated the hinge pin on the instrument wrist was protruding outwards preventing it from fitting through the cannula.Technical service engineer (tse) walked the customer through removing the instrument and cannula together.After successfully removing the cannula and instrument together the customer was continuing as planned.A backup instrument was used.Tse recommended returning the instrument for failure analysis.The procedure was completed as planned with no reported injury.

Manufacturer Narrative

The reported event was addressed with phone support.Technical service engineer (tse) walked the customer through removing the instrument and cannula together.After successfully removing the cannula and instrument together the customer was continuing as planned.No site visit was conducted.The system was working properly, and no additional action was required as the issue was resolved.

• Brand Name: ENDOWRIST
• Type of Device: FORCE BIPOLAR
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 19150665
• MDR Text Key: 341245810
• Report Number: 2955842-2024-13676
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(11)230515(10)K10230515(91)0003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K214095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471405-06
• Device Catalogue Number: 471405
• Device Lot Number: K10230515 0235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.