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

Model Number	470400-07
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The long bipolar grasper instrument involved with this event has been received, but the failure analysis testing has not yet been completed as of the date of this report.A follow-up mdr will be submitted when failure analysis has completed their investigation.
Event or Problem Description
It was reported that during central processing, the distal tip of the long bipolar grasper instrument was loose.The black wire was out of place.There was no report of patient involvement.
Additional Manufacturer Narrative
The long bipolar grasper instrument was analyzed and found with a segment of the conductor wire dislodged and sticking out from the proximal clevis.A loop of wire protrudes above the outer surface of the main tube.The wire insulation was not damaged.The instrument grips were manually manipulated, and the instrument passed an electrical continuity test on 3 out of 3 attempts.Components adjacent to the dislodged wire did not show damage.The complaint was confirmed by failure analysis.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: BIPOLAR GRASPER, LONG
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 19469139
• Report Number: 2955842-2024-15446
• Device Sequence Number: 7423929
• Product Code: NAY
• UDI-Device Identifier: 00886874113530
• UDI-Public: (01)00886874113530(10)S10170301
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

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: S10170301 0062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 06/08/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 07/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2017
• 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: Prefer Not To Disclose