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

Model Number 470405-06

Device Problems Break (1069); Difficult to Remove (1528); Material Twisted/Bent (2981)

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

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the force bipolar (fb) instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation did not replicate nor confirm the customer reported complaint of breakage of the cable.The customer also reported a complaint of a "bent jaw." this complaint was confirmed.The instrument was found to have a severely bent grip, and the tip did not align with the other grip.This failure is most commonly caused by mishandling/misuse, such as excess force applied to the instrument jaws.

Event Description

It was reported that during a da vinci-assisted inguinal hernia repair surgical procedure, the surgeon had a collision with the monopolar curved scissors (mcs) instrument and a force bipolar (fb) instrument.As a result, the fb instrument's cable was broken and the jaws were bent.An instrument release kit (irk) was used to remove the instrument from the cannula.The procedure was completed with no report of patient harm, injury or adverse outcome.Intuitive surgical, inc.(isi) follow-up with the customer and confirmed no fragment fell inside the patient.The surgeon believes the cause of the instrument breakage was from the arm collision.The instrument was reportedly inspected prior to use, and no issues were noted.The surgeon was dissecting tissue at the time of the event, and the instrument performed as intended up until it broke.The customer used an irk, but it would not release the instrument due to the tip of the instrument being broken/snapped.There was no adverse effect to the grasped tissue and no unexpected tissue removal.There was no unexpected bleeding.There were no post-operative complications.It was confirmed there was no patient harm, and the patient was discharged from the hospital.

• 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: 17015990
• MDR Text Key: 317344869
• Report Number: 2955842-2023-15099
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)N10200323
• 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
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/10/2020

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: 470405-06
• Device Catalogue Number: 470405
• Device Lot Number: N10200323 0089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 05/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2020
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Hispanic