MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MICRO BIPOLAR FORCEPS

Model Number	471171-15
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted cardiac surgical procedure, at the end of the surgical procedure, the steel cable at the tip of the micro bipolar forceps joint came loose completely.As it was at the end of the surgery, it was not necessary to use another clamp.Instrument have 10 lives remaining.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information: the customer clarified that the damage to the material was identified outside the patient, during the change of clamps, i.E.Outside the surgical field and not during direct use on the patient.There were no reports of fragments falling from the device during use on the patient, nor any injury or complication related to the retention of material.There was also no need for the patient to return to hospital for this reason.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The micro bipolar forceps instrument was analyzed and found to have a broken monopolar yaw pulley at the distal clevis.Broken pieces are missing as a result of breakage.Size of missing piece is approximately 0.010¿ x 0.110¿.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 broken conductor wire at the yaw pulley.The instrument failed the electrical continuity test, confirming a complete break in the wire.No thermal damage was found on the instrument.Components adjacent to the broken wire do not show damage.Further, the instrument was found to have the cable crimp from wrist control cable at the yaw pulley.As a result, the instrument lost the ability to move freely.The cable crimp is captured inside the welded grip.The complaint was confirmed by failure analysis.The probable root cause of a broken bipolar yaw pulley is attributed to damage during use, which may result from applying excess force on the distal end of the instrument during handling, insertion, usage (overloading), or removal.The probable root cause of broken conductor wire is attributed to component susceptibility to damage through external collisions, during use, or during reprocessing.The probable root cause of cable crimp is attributed to a component failure.These issues can be resolved by using an alternate instrument to complete the procedure.

• Brand Name: ENDOWRIST
• Common Device Name: MICRO BIPOLAR FORCEPS
• 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: 21904624
• Report Number: 2955842-2025-16782
• Device Sequence Number: 19835811
• Product Code: NAY
• UDI-Device Identifier: 00886874121474
• UDI-Public: (01)00886874121474(11)230913(10)K10230913(91)0043
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K214095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2025

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: 471171-15
• Device Catalogue Number: 471171
• Device Lot Number: K10230913 0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• 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 Age: 47 YR
• Patient Sex: Male