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 Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Refer to h11 for follow-up information.
Event or Problem Description
A patient in a study underwent a da vinci-assisted benign hysterectomy procedure.On the first postoperative day, an increased volume of bloody fluid was noted at the drainage.An ultrasound evaluation revealed a hematoma in the douglas pouch measuring 78 x 38 x 82 mm.The patient reported increasing dizziness, and laboratory tests showed a declining hemoglobin level, leading to the decision to initiate treatment.This revealed a hemoperitoneum with a volume of approximately 600 ml.A small source of bleeding on the greater omentum was coagulated, and the area was thoroughly irrigated; there was no blood transfusion.The event led to a prolonged hospitalization; discharged occurred 4 days after surgery.The study investigator reported the event as mild severity, not a serious adverse event, a clavien-dindo grade iiib, possibly related to the study procedure and possibly related to the patient's underlying disease status.
Additional Manufacturer Narrative
Additional information: a review of the event was conducted by an intuitive surgical, inc.(isi) medical officer and concluded that the patient in this report had post operative bleeding following a hysterectomy.The omentum was later determined to be the source of the bleed.How the omentum was encountered or manipulated during the procedure and how it may have bled is not provided.Therefore, it is possible this bleed is device related.Bleeding may also be procedure related and therefore an association to the procedure is possible.Patient related factors are another possible relationship.
Additional Manufacturer Narrative
There was no report that a da vinci system, instrument or accessory malfunctioned during the procedure.Additional patient information: height 175 cm., body mass index (bmi) 21.9 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: 50072048
• Report Number: 2955842-2026-33171
• Device Sequence Number: 16042580
• 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,Followup
• Report Date (Section B): 09/16/2026

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?: No
• Initial Date Received by Manufacturer: 07/02/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 09/16/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 147 LB