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

Model Number	470400-07
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the long bipolar grasper instrument for evaluation as of the date of this report.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, a fragment fell off the long bipolar grasper instrument and into the patient.The fragment was retrieved during the same procedure.The procedure was completed robotically.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the long bipolar grasper instrument associated with this complaint and completed investigations.Failure analysis found the primary failure of broken yaw pulley to be related to the customer reported complaint.The instrument was found to have a broken bipolar yaw pulley near the cable routing.Broken piece was missing because of breakage.Size missing piece is approximately 2.63mm x 4mm.The components surrounding the break did not exhibit damage that would have contributed to the broken yaw pulley.Additionally, the instrument was found to have a segment of the conductor wire dislodged from the yaw pulley.A loop of the wire protrudes above the outer surface of the main tube.The wire insulation was not damaged the instrument passed the electrical continuity test.Components adjacent to the dislodged wire do not show damage.The instrument was found to have damaged conductor wire insulation at the yaw pulley.There was no fragmentation of the insulation, and the internal conductor wires were not exposed.Although the conductor wire insulation was damaged, the internal wire was not frayed or fully broken.The instrument passed the electrical continuity test.Further inspection found no abnormally sharp or damaged components that could have contributed to the cable breaking.
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: 20341175
• Report Number: 2955842-2024-19815
• Device Sequence Number: 20816136
• Product Code: NAY
• UDI-Device Identifier: 00886874113530
• UDI-Public: (01)00886874113530(10)N10170927
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 470400-07
• Device Catalogue Number: 470400
• Device Lot Number: N10170927 0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown