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

Model Number	470400-07
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Arcing (2583); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the long bipolar grasper instrument's black cord was damaged.The instrument was not used.It was replaced and surgery was completed.No fragments fell into the patient.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The long bipolar grasper instrument was analyzed and reported failure was confirmed.1.The instrument was found to have a piece of the conductor wire insulation damaged near the end that attaches to the yaw pulley.The wires were exposed.The instrument passed the electrical continuity test.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips did not open and close properly due to damage to the yaw pulley and the cable crimp not secured.The instrument released energy normally.No arcing was observed.2.The instrument was found to have a broken bipolar yaw pulley.Broken piece is missing as a result of breakage.Size of missing piece is approximately 0.124¿ x 0.079¿.3.The instrument was found to have charring and localized melting on the bipolar yaw pulley.The thermal damage was found at the base of the yaw pulley near the grip.As a result, the electrode was exposed.The instrument grips were manually manipulated, and the instrument passed an electrical continuity test on three out of three attempts.The instrument was placed and driven on an in-house system.

• 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: 17962385
• Report Number: 2955842-2023-19375
• Device Sequence Number: 12717885
• Product Code: NAY
• UDI-Device Identifier: 00886874113530
• UDI-Public: (01)00886874113530(10)N10170328
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/26/2023

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: N10170328 0064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2017
• 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