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

Model Number	470405-06
Medical Device Problem Codes	Difficult to Open or Close (2921); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer noted that 45 minutes into the case, the force bipolar instrument wrist became offset and the jaws would not open.The customer indicated the instrument could not be removed and then was removed with the trocar.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the charge nurse informed the reported issue occurred during a robotic hiatal hernia repair with nissen fundoplication.It was noted that no tissue was stuck inside the instrument jaws and no tissue need to be removed.The charge nurse did not know if the force bipolar instrument was in force grip mode.No medical intervention was require, nor was blood lost.The instrument was pulled out and replaced.No fragments fell into the patient.It was noted the patient was a 46-year-old female who weighed 94.5 kg and birthday is (b)(6)1974.The charge nurse confirmed the procedure was completed robotically with no patient injury or harm.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the parts involved with this complaint and completed the device evaluation.Failure analysis did not replicate/confirm the customer reported issue.Mechanical testing was performed, the unit was installed into the test system and passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.A visual inspection was performed and found the conductor wire to be broken at the distal end.The instrument failed an electrical continuity test.

• Brand Name: ENDOWRIST
• Common Device Name: 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: 17016007
• Report Number: 2955842-2023-15110
• Device Sequence Number: 6975639
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)N10190228
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K180351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2020

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
• Operator of Device: Health Professional
• Device Model Number: 470405-06
• Device Catalogue Number: 470405
• Device Lot Number: N10190228 0056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 05/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 94 KG