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

Model Number	430010-62
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The maryland bipolar forceps instrument was found to have the proximal clevis dislodged.Visual inspection found that both welds were present on the clevis.The root cause of this failure is attributed to user.The complaint was confirmed based on the failure analysis.The probable root cause is attributed to the user.
Event or Problem Description
It was reported that after a da vinci-assisted radical prostatectomy surgical procedure, the sheaths were removed from all the instruments, and the front part of the instruments felt loose.Upon inspection, it appeared that the flexible part was separated.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument/accessory was inspected prior to use and was found to be in good condition, with no damage or anything out of the ordinary.During the surgical procedure, the surgeon did not notice any issues with the instrument's functionality, and there were no collisions with other instruments or hard materials.Consequently, no fragments fell inside the patient, and no post-operative tests such as x-rays or ultrasounds were performed to check for remaining fragments.The procedure was completed robotically without any injury to the patient.Furthermore, the patient has not returned to the hospital due to any post-surgical complications related to retaining a foreign object.Patient demographic information and relevant medical history are unavailable, as the customer stated it could not be disclosed.Additionally, there are no relevant tests, results, or dates available.
Additional Manufacturer Narrative
The single-port (sp) maryland bipolar forceps instrument was further evaluated by failure analysis engineer (fae) and the initial fa was partially confirmed.The dislodged proximal clevis was confirmed; however, it was found to potentially due to a manufacturing issue.The images of the welds were sent to the manufacturing engineer of laser welding for single-port (sp) instruments, and it noted, "it looks like the weld is way off the weld seam and not dead center".The instrument's proximal clevis had areas which are laser welded during manufacturing to join the component with the upper most, most distal wrist disc.While both welds were present and did not exhibit other defects, one weld was found to be off-center as indicated by the visible shoulder on the wrist disk which is typically not visible on a properly centered weld.Because the weld is off-center, it could lead to a reduction in strength of the weld which could lead to the dislodged proximal clevis.As the weld is performed during manufacturing, the root cause of the dislodged proximal clevis appears to be attributed to manufacturing.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST SP
• Common Device Name: MARYLAND 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: 23068562
• Report Number: 2955842-2025-38258
• Device Sequence Number: 10044929
• Product Code: NAY
• UDI-Device Identifier: 00886874114322
• UDI-Public: (01)00886874114322(11)250130(10)K10250130
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K182371
• 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): 08/24/2025

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: 430010-62
• Device Catalogue Number: 430010
• Device Lot Number: K10250130 0016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/24/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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