MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; CROCKODILE GRASPER

Model Number	478059-04
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the jaw wrist of the crocodile grasper instrument was separated.The fragment was retrieved during the same procedure and was confirmed to be retrieved under direct visualization.No additional surgical procedure was required to remove the fragment.An x-ray was performed to check for remaining fragments.The procedure was completed robotically with a back-up instrument.
Additional Manufacturer Narrative
The crocodile grasper instrument has not been received for failure analysis evaluation.
Additional Manufacturer Narrative
The crocodile grasper instrument was received, and failure analysis found the instrument to have a completely broken grip tip.Pieces approximately 0.960" x 0.190" were found to be broken off.The broken pieces were not returned with the instrument.Further inspection found a broken distal clevis.The instrument was found to have a broken distal clevis at the base of the clevis.The broken pieces were not returned, measuring roughly 0.1530¿ x.2930" in size.The clevis did not show abrasions or scratches on the outer surface.Components adjacent to the broken clevis showed damage which may indicate potential mishandling/misuse.The grip tip was completely broken and missing.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: SINGLE-SITE
• Common Device Name: CROCKODILE GRASPER
• 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: 22436708
• Report Number: 2955842-2025-28852
• Device Sequence Number: 4708788
• Product Code: NAY
• UDI-Device Identifier: 00886874113639
• UDI-Public: (01)00886874113639(11)230831(10)K10230831
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K152448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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: 478059-04
• Device Catalogue Number: 478059
• Device Lot Number: K10230831 0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown