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

Model Number	470344-13
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure the tip of the curved bipolar dissector did not align.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the curved bipolar dissector associated with this complaint and completed investigations.Failure analysis investigations replicated and confirmed the customer reported complaint.The instrument was found to have a bent grip, causing side to side misalignment of the grips.There was a 0.049¿ offset at the tips.Bent grips with an offset < 0.05¿ is attributed to damage during use, as moderate misalignment of grip tips can be due to grasping either hard tissue/objects or collisions with other instruments.Also, the curved bipolar dissector instrument was found to have a broken conductor wire at the yaw pulley.The conductor wire was broken at the grip-crimp location.The curved bipolar dissector 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 is missing as a result of the breakage.Size of missing piece is approximately 0.125¿ x 0.075¿.

• Brand Name: ENDOWRIST
• Common Device Name: CURVED BIPOLAR DISSECTOR
• 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: 17000317
• Report Number: 2955842-2023-14548
• Device Sequence Number: 2317629
• Product Code: NAY
• UDI-Device Identifier: 00886874112489
• UDI-Public: (01)00886874112489(10)N11151022
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/24/2023

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: 470344-13
• Device Catalogue Number: 470344
• Device Lot Number: N11151022 0016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2015
• 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