MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; PROGRASP FORCEPS

Model Number	420093-14
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has requested that the prograsp forceps instrument be returned for failure analysis testing.As of the date of this report, the product has not yet been received.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, part of the rod was broken at the joint of the 8mm prograsp forceps instrument.No fragments fell into the patient.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The instrument was analyzed and found to have a broken main tube approximately 1.8640 from the distal tip.No piece was missing.Components adjacent to this broken main tube do not show damage.The complaint was confirmed by failure analysis.The probable root cause is attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments.Excessive side loading on the instrument can also cause the main tube wall to collapse inwards leading to cracking and subsequent breakage.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: PROGRASP 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: 21658250
• Report Number: 2955842-2025-10144
• Device Sequence Number: 18377662
• Product Code: NAY
• UDI-Device Identifier: 00886874111345
• UDI-Public: (01)00886874111345(10)K10240104
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2025

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: 420093-14
• Device Catalogue Number: 420093
• Device Lot Number: K10240104 174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• 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