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

Model Number 470405-06

Device Problems Difficult to Remove (1528); Difficult to Open or Close (2921)

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

Event Date 02/03/2021

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated/confirmed the customer reported complaint.The instrument was found to have a severely bent grip at the base of the grip where it meets the distal pin.Part of the grip's base is bent outwards.The severely bent grip base makes the instrument unable to be taken off from the cannula and the cannula seal.As a result, the cannula and cannula seal are stuck to the instrument.

Event Description

It was reported that during a da vinci-assisted ventral hernia repair surgical procedure, the force bipolar instrument would not release from tissue.The customer stated that they had to use a stapler release kit (srk) and were able to release the instrument jaws.The customer reported that the bipolar instrument was caught in the trocar, and the bipolar instrument and trocar were pulled out together as one piece.The customer also informed the technical support engineer (tse) that they found no debris in the patient.The procedure was completed as planned with no report of patient harm, injury or adverse outcome.Intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: the issue occurred when the surgical staff was trying to exchange/remove instruments.The scrub technician was unable to remove the instrument, and the surgeon scrubbed back in and removed the instrument and cannula together as one piece after they undocked.The surgeon looked around to ensure there were no other injuries or retained items in the patient.Upon inspection, the customer found some parts of the instrument had caught on the end of the cannula, making it physically unable to separate the two pieces.The customer admitted to using a stapler release kit (srk) instead of an instrument release kit (irk) to release the instrument.By the time the customer realized the mistake, the surgeon had already scrubbed in and removed the instrument and cannula.

• 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: 17093839
• MDR Text Key: 316844688
• Report Number: 2955842-2023-16097
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)N10200713
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/03/2021

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: 470405-06
• Device Catalogue Number: 470405
• Device Lot Number: N10200713 0064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2020
• 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 Age: 35 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White