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

Model Number	471190-04
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the cobra grasper instrument to perform failure analysis.The instrument was analyzed and found to have a broken grip at the base of the grip tip.A piece measuring approximately 16.86mm x 5.38 mm in size was found to be broken off.The broken piece was not returned with the instrument.
Event or Problem Description
It was reported that during a da vinci-assisted benign hysterectomy procedure, the tip of the cobra grasper instrument broke.A fragment fell inside the patient and was retrieved during the same procedure which was completed robotically.

• Brand Name: ENDOWRIST
• Common Device Name: COBRA 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: 21620902
• Report Number: 2955842-2025-05501
• Device Sequence Number: 15587349
• Product Code: NAY
• UDI-Device Identifier: 00886874121481
• UDI-Public: (01)00886874121481(10)K10230405
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K214095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/17/2025

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: 471190-04
• Device Catalogue Number: 471190
• Device Lot Number: K10230405 0246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2023
• 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