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

Model Number	470400-09
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the long bipolar grasper instrument involved with this complaint to perform failure analysis; however, the evaluation is not yet complete.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the long bipolar grasper instrument was partially damaged.A fragment fell inside the patient and was retrieved during the same procedure which was completed robotically.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the long bipolar grasper instrument was inspected prior to use and no damage was noted.The instrument was in use for several hours before the breakage occurred.The surgeon did not notice any issues with the functionality of the instrument.It is unknown if the instrument collided with any other instruments or other hard material during the surgical procedure.The surgical staff did not notice any damage to the cannula after the event occurred.The fragment(s) were collected in a bag inside the patient's body.The customer confirmed that all the pieces were recovered.No additional surgical procedures were required to remove the fragments.There were no postoperative tests like an x-ray or ultrasound were performed to check for remaining fragments.The procedure was completed robotically with no injury to the patient.The patient has not returned to the hospital due to experiencing any post-surgical complications.The instrument and the fragments are available for return.There are no photographic images of the device or video recordings of the procedure available.
Additional Manufacturer Narrative
Updated sections, h3, annex codes: g, c, d.Device evaluation: an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) received the long bipolar grasper instrument to perform failure analysis (fa) and was able to confirm and replicate the customer reported complaint.The instrument was found to have a broken bipolar yaw pulley near the grip.A broken piece was missing because of the breakage and it was not returned with the instrument.The components surrounding the break did not exhibit damage that would have contributed to the broken yaw pulley.

• 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: 21637942
• Report Number: 2955842-2025-07665
• Device Sequence Number: 20509749
• Product Code: NAY
• UDI-Device Identifier: 00886874113530
• UDI-Public: (01)00886874113530(10)N10180815
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

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: 470400-09
• Device Catalogue Number: 470400
• Device Lot Number: N10180815 0043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2018
• 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