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

Model Number	470400-07
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the long bipolar grasper did not work and had wires exposed.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
The long bipolar grasper has been returned and evaluated by the failure analysis team.The instrument was found to have a broken conductor wire at the yaw pulley.The conductor wire was broken at the grip-crimp location.The instrument failed the electrical continuity test.No signs of thermal damage were observed.The instrument was found to have a broken bipolar yaw pulley.Broken piece was missing as a result of breakage.Size of missing piece was approximately 0.143¿ x 0.024¿.This failure was most commonly caused by mishandling/misuse, such as excess force applied to the distal end of the instrument.The instrument was found to have various scratch marks with light material removed on the main tube.The scratch marks were 0.167¿ - 0.155" in length and were not aligned with the tube axis.This failure was most commonly caused by mishandling/misuse.

• 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: 17016026
• Report Number: 2955842-2023-15133
• Device Sequence Number: 17886529
• Product Code: NAY
• UDI-Device Identifier: 00886874113530
• UDI-Public: (01)00886874113530(10)N10170130
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2020

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: 470400-07
• Device Catalogue Number: 470400
• Device Lot Number: N10170130 0064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 05/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2017
• 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: Unknown