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

Model Number	430152-02
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci¿assisted transaxillary thyroidectomy procedure, a fragment from the maryland bipolar forceps instrument broke off and became lodged in tissue that was dissected.The fragment was recovered along with the soft tissue of the thyroid nodule, which was already planned for removal.The surgery proceeded using a replacement maryland bipolar forceps instrument.No additional procedure was required, and no postoperative imaging was performed.The patient has not experienced any postoperative complications.Additionally, the patient's current medical status was noted as good.The surgeon did not observe any functional issues with the instrument during use.
Additional Manufacturer Narrative
The maryland bipolar forceps instrument has not been received for failure analysis evaluation.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The maryland bipolar forceps instrument was analyzed and found to have a broken molded insulator on the upper jaw.Due to the broken molded insulator, one of the entire grip tips appeared to be completely detached from the instrument.The grip base for the grip with the cracked molded insulator did not appear to be bent.The three broken pieces retrieved measured approximately 4.30mm x 15.17 mm, 1.38mm x 8.24mm and 2.12mm x 2.13mm, confirming that a fragment detached from the instrument and was returned with the instrument.The housing was removed for inspection and found no damage.The inputs were manually articulated, and the roll, joggle, pitch and yaw went to the right directions.Additional observation related to the customer complaint was that the instrument was found to have detached fragments from the broken molded insulator.The three detached fragments that were returned measured approximately 4.30mm x 15.17 mm, 1.38mm x 8.24mm and 2.12mm x 2.13mm.The detached fragments were the grip tip and some parts were from the molded insulator.The instrument was found to have a broken conductor wire at the distal base.The instrument failed the electrical continuity test, confirming a complete break in the wire.No thermal damage was found on the instrument.The conductor wire was likely broken due to the molded insulator damage.The complaint was confirmed by failure analysis.
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: 24286115
• Report Number: 2955842-2026-03011
• Device Sequence Number: 15990898
• Product Code: NAY
• UDI-Device Identifier: 00886874123461
• UDI-Public: (01)00886874123461(11)250731(10)K10250731
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K241814
• 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): 02/23/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 430152-02
• Device Catalogue Number: 430152
• Device Lot Number: K10250731 0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 02/07/2026
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• 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: 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 Sex: Unknown