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

Model Number	430009-62
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The single port cadiere forceps instrument has been evaluated by the failure analysis (fa) team.The instrument was found to have a dislodged proximal clevis.The dislodged proximal clevis was found at weld 4, the location of the distal main tube.The welds were inspected and appeared to be present on both sides and did not show signs of workmanship or burn-back issues.The distal grip tips were still attached to the instrument due to the internal components.No material was found missing.The housing was removed and found to be undamaged.The inputs were manually articulated and passed.The grips open and closed when the grip knob is manually rotated despite the damage.The root cause is typically attributed to the use conditions.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, user informed an intuitive surgical, inc.(isi) technical support engineer (tse) that the movement of the single port cadiere forceps instrument on the screen appeared to be abnormal.As the case progressed, creaking was observed on the screen when opening and closing the jaw of the cadiere forceps instrument.At the request of the surgeon, the instruments were inspected, and it was confirmed that the shaft and jaw of the cadiere forceps had become dangling and detached upon inspection of the instrument sheath.The instrument was removed and replaced with a backup.Following this, the user continued and completed the procedure with no further issues.No fragment fell into the patient.No known impact or patient consequence was reported.

• Brand Name: ENDOWRIST SP
• Common Device Name: CADIERE 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: 25203238
• Report Number: 2955842-2026-25453
• Device Sequence Number: 21336909
• Product Code: NAY
• UDI-Device Identifier: 00886874115213
• UDI-Public: (01)00886874115213(11)250529(10)K10250529
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K182371
• 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
• Report Date (Section B): 05/18/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 430009-62
• Device Catalogue Number: 430009
• Device Lot Number: K10250529 0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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
• Patient Sex: Female