MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC da Vinci SP; PATIENT SIDE CART

Model Number	380601-50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient in a study underwent a da vinci-assisted benign hysterectomy and parametrectomy with bilateral salpingo-oophorectomy procedure.The study procedure was completed without intra-operative adverse events and no reported da vinci device malfunctions.Two days after surgery, it was reported that the patient had post-operative elevated c-reactive protein (crp).There were no other signs of infections and the event was resolved with antibiotic therapy.There was no prolonged hospitalization and discharge occurred six days after surgery.The study investigator reported the event as mild severity, not a serious adverse event, a clavien-dindo grade ii, having a causal relationship to the study procedure, but not related to the patient's underlying disease status, not related to the da vinci investigational device, and not related to a third-party device.The patient's prior health conditions of copd and possible pneumonia may be relevant to this incident.
Additional Manufacturer Narrative
There was no report that a da vinci system, instrument or accessory malfunctioned during the procedure.Additional patient information: height: 164 cm., body mass index (bmi) 20.1 kg/m2.

• Brand Name: da Vinci SP
• Common Device Name: PATIENT SIDE CART
• 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: 50356680
• Report Number: 2955842-2026-36190
• Device Sequence Number: 6039197
• Product Code: NAY
• UDI-Device Identifier: 00886874114605
• UDI-Public: (01)00886874114605
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 380601-50
• Device Catalogue Number: 380601
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2024
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 118 LB