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

Model Number 470405-06

Device Problem Difficult to Remove (1528)

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

Event Date 06/17/2020

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 replicated and confirmed the reported complaint.The fb instrument was found to have a broken grip cable at the proximal end.

Event Description

It was reported that during a da vinci-assisted total ovarian cystectomy surgical procedure, a second force bipolar (fb) instrument wrist was broken during the same procedure.The operating room (or) director noted the surgeon was working with the instrument arm at a 180 degree when the jaw became stuck and the staff was unable to remove it.It was confirmed that there was no tissue was stuck in fb instrument jaws, the fb instrument had been in use for 2.5 hour prior to it becoming stuck, and the customer did not use the instrument release kit (irk) tool.The customer was able to remove the cannula and then remove the instrument.The procedure was completed with no reported injury or harm.

• 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: 17015993
• MDR Text Key: 317274853
• Report Number: 2955842-2023-15097
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)N10200127
• 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,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/18/2020

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: N10200127 0239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 05/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2020
• 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: 20 YR
• Patient Sex: Female
• Patient Weight: 99 KG