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

Model Number	471400-10
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy procedure, the long bipolar grasper instrument tip broke.A fragment fell into the patient and was retrieved during the same procedure.The customer confirmed the fragment was located in a suction canister.It was removed and matched with the long bipolar grasper instrument along the break line.The surgeon confirmed full fragment retrieval.No post-operative tests were performed.No additional procedure was required.The procedure was completed.There were no complications and the patient has not returned to the hospital due to experiencing any post-surgical complications related to the event.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The long bipolar grasper instrument was analyzed and found to have a broken grip at the midpoint of grip.A piece approximately 2.85mm x 7.09mm was found to be broken off, confirming that a fragment detached from the long bipolar grasper instrument.The broken piece was not returned with the instrument.Further inspection of the returned long bipolar grasper instrument found no additional damage or abnormalities.

• 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 ; +1(408)523-2100
• MDR Report Key: 50193631
• Report Number: 2955842-2026-35147
• Device Sequence Number: 9998723
• Product Code: NAY
• UDI-Device Identifier: 00886874121528
• UDI-Public: (01)00886874121528(11)231012(10)K10231012(91)0085
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 471400-10
• Device Catalogue Number: 471400
• Device Lot Number: K10231012 0009
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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: Initial
• 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 Age: 73 YR
• Patient Sex: Male
• Patient Weight: 195 LB
• Patient Race: White