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 05/25/2023

Event Type  Injury  

Manufacturer Narrative

Based on the claim against the product by the customer noting force bipolar shaft broke inside the patient and the jaws were stuck in the closed position, 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.Review of the provided image is consistent with the force bipolar instrument distal clevis is dislodged.

Event Description

It was reported that during a da vinci-assisted unilateral inguinal hernia bilateral surgical procedure, the intuitive surgical, inc.(isi) clinical sales representative (csr) informed the isi technical support engineer (tse) that a force bipolar instrument's shaft broke at the distal end on arm 2.The customer had to de-cannulate the instrument, arm and cannula from patient as the instrument was bent and they couldn't remove it normally.The customer re-docked arm 2 and installed another instrument and cannula and completed the case.After the case the customer inspected the patient for fragments, laparoscopically and with the robot and found no fragments.The customer reported no injuries.The customer will return the instrument and the cannula together.The procedure was completed as planned with no reported injury.Isi followed up with the csr and obtained the following additional information: the csr stated the hospital followed normal reprocessing procedures were followed.The endoscope collided with the instrument and the jaws of the force bipolar instrument were stuck in a closed position prior to remove the instrument.The csr stated the surgeon inspected visually using the endoscope to verify that there were no fragmentation or pieces of the instrument in the body of the patient.There was no increased incision size or additional port placement.

• 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: 17174945
• MDR Text Key: 317630323
• Report Number: 2955842-2023-16473
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)K10220808
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471405-06
• Device Catalogue Number: 471405
• Device Lot Number: K10220808 0010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2022
• 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: Male