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 06/02/2023

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the customer reported encountering an insertion axis not free to move message.The intuitive surgical, inc.(isi) technical service engineer (tse) recommended the customer to remove the force bipolar instrument and ensure carriage was free to move.The customer explained they were unable to remove the instrument from the universal surgical manipulator (usm) as the jaws would not pass through the cannula.The tse explained the customer would have to move the usm with the instrument and cannula installed away from the patient and remove the instrument with the cannula at the same time.The customer removed the instrument with the cannula and installed a new instrument/cannula.The customer was proceeding with the procedure.The tse recommended the staff to return the broken force bipolar instrument.The procedure was completing as planned with no reported injury.Isi followed up with the robotics coordinator and obtained the following additional information: the instrument was checked by surgical technician and no damages were noted.The grips/jaws would not close.The port incision was not increased to remove the instrument and cannula together.No fragments fell into the patient.No abnormalities of the instrument were observed.

Manufacturer Narrative

Based on the claim against the product by the customer noting the jaws of the force bipolar instrument would not close and this caused the customer to remove the instrument with the cannula out of the patient together, an investigation is in progress to determine the cause of this reported event.Intuitive surgical, inc.(isi) has not received the force bipolar instrument for evaluation.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.

• 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: 17235343
• MDR Text Key: 318320388
• Report Number: 2955842-2023-16714
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)K10230212
• 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: 06/02/2023

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: 471405-06
• Device Catalogue Number: 471405
• Device Lot Number: K10230212 0096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2023
• 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
• Patient Sex: Female