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

Model Number	470344-14
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the 8mm curved bipolar dissector instrument for failure analysis investigation.The instrument was analyzed and was found to have a broken bipolar yaw pulley at the grip hub.Broken pieces are missing as a result of breakage.Size of missing piece is approximately 0.0925¿ x 0.0460¿.The components surrounding the break did exhibit damage that would have contributed to the broken yaw pulley.The grip tips are bent and have indentations.Additional observations related to customer reported complaint: the instrument was found to have one bent grip, causing misalignment of the grips.There was a.0325¿ offset at the tips.The grips do show damage.The tips have indentations.Components adjacent to this bent grip do show damage.The yaw pulley is broken and pieces missing.The instrument was found to have multiple indentations/burrs at the tip of the grip tips.The grips were found to be bent.Components adjacent to the indented grip tips show damage which may indicate potential mishandling/misuse.The yaw pulley is broken.
Event or Problem Description
It was reported that during central processing, the 8mm curved bipolar dissector instrument was found to have broken plastic at the tip of the instrument.There was no report of patient involvement.

• Brand Name: ENDOWRIST
• Common Device Name: CURVED BIPOLAR DISSECTOR
• 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: 20434955
• Report Number: 2955842-2024-20651
• Device Sequence Number: 8402688
• Product Code: NAY
• UDI-Device Identifier: 00886874112489
• UDI-Public: (01)00886874112489(10)N10170928
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• 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): 09/24/2024

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: 470344-14
• Device Catalogue Number: 470344
• Device Lot Number: N10170928 0091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 10/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2017
• 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: Prefer Not To Disclose