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

Model Number	470405-06
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted total malignant hysterectomy surgical procedure, the force bipolar did not move.The customer removed the instrument to check and found that the metal tip covering the wire came out and did not open.There was no report of fragment(s) falling inside the patient.The procedure was completing as planned with another instrument.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use with no damage observed.The instrument was being used for dissecting the tissue, then the metal cover of the silver wire was dislodged.No loss of cautery or damage noticed.The instrument did not collide with any other instrument or tool during the procedure.There were no signs of thermal damage observed.No fragment fell inside the patient.The procedure was completed with a backup instrument, and there was no reported patient injury.Photographic images of the device(s) was provided for isi review.Information regarding patient demographics, relevant testing, and medical history were requested however, the reporter was not able to provide that information.Upon further follow up, the customer confirmed that the instrument was not grasping a tissue.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the force bipolar instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated and confirmed the customer reported complaint "during a procedure, instrument wasn't working, and customer found iron tip which covered cables was popped out and tip wasn't opened".The instrument was found to have a segment of the conductor wire sticking out from the distal end.A loop of wire is sticking out such that the wire protrudes above the outer surface of the grip tips assembly.This failure can affect the opening of the grip tips.The instrument failed an electrical continuity test.Additionally, fa found the instrument to have a broken conductor wire at the distal end.No signs of thermal damage were observed.The instrument was found to have damage to the conductor wires insulation at the distal end.The conductor wire was exposed as a result.The instrument failed the electrical continuity test.No signs of thermal damage observed.The instrument also was found to have mechanical indentation damage to the distal pulley.No material missing.The damaged pulley is located near the defective conductor wire.The instrument was found to have mechanical indentation/burrs to the grip tips.No material missing.The grip tip damage is located near the defective conductor wire.

• 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: 17067918
• Report Number: 2955842-2023-15909
• Device Sequence Number: 20527013
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)N10201019
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K180351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2021

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: N10201019 0046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2020
• 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: Initial
• 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