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

Model Number	470400-07
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.The long bipolar grasper instrument was analyzed.The instrument was found to have a broken conductor wire at the distal end.It was placed and driven on an in-house system, and it passed recognition and engagement tests but failed the electrical continuity and energy delivery tests.The instrument exhibited intuitive movement with a full range of motion in all directions, and the grips opened and closed properly.A visual inspection revealed no thermal damage, and while no portion of the conductor wire insulation was missing, the wires were exposed.Further evaluation found the instrument had a broken bipolar yaw pulley, with a missing piece measuring approximately 0.192" x 0.037".The instrument was also found to have a dislodged flush tube.Corrosion signs were discovered on the instrument bearings, specifically orange discoloration on the grip input disk bearings.Additional dried residue was found around the clamping pulley cable groove.
Event or Problem Description
It was reported that during a da vinci-assisted hysterectomy surgical procedure, the surgeon was unable to use the instrument due to bipolar cord being detached.The area was inspected, and surgeon didn't see anything in the abdomen.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter on and obtained the following additional information: the outer area of an instrument was inspected; however, it was not noticed until the jaws were opened.The issue was noticed intraoperatively.Once the jaws were opened it was noticed that cord was broken.The instrument did not collide with another instrument.There were no problems removing through the cannula.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
There were no fragments seen and the patient did not return to the hospital for foreign object.

• Brand Name: ENDOWRIST
• Common Device Name: BIPOLAR GRASPER, LONG
• 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: 18156262
• Report Number: 2955842-2023-20300
• Device Sequence Number: 6467482
• Product Code: NAY
• UDI-Device Identifier: 00886874113530
• UDI-Public: (01)00886874113530(10)N10180425
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K150837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2023

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: 470400-07
• Device Catalogue Number: 470400
• Device Lot Number: N10180425 0193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2018
• 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 Sex: Female