MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; PATIENT SIDE CART, RECERTIFIED

Model Number	380686-04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that during a da vinci-assisted salpingo-oophorectomy surgical procedure, the procedure was going well; however, the patient had a lot of adhesions and found the uterus was very attached to the intestine so the surgeon made the decision to convert the procedure to open.There was no allegation of a product malfunction.As such, no product is expected to be returned for investigation.This complaint is considered a reportable event due to the following conclusion: the surgeon converted the da vinci-assisted procedure to an open after the start of the procedure.
Event or Problem Description
It was reported that during a da vinci-assisted salpingo-oophorectomy surgical procedure, the procedure was going well; however, the patient had a lot of adhesions and found the uterus was very attached to the intestine so the surgeon made the decision to convert the procedure to open.This was the patient's third surgery.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information: the system was inspected by the biomedical staff prior to use with no issue identified.The procedure had been in progress about 1 hour when the surgeon noticed the rectum was very attached to the uterus.The procedure converted to open solely due to patient anatomy to avoid risks to the patient.The patient tolerated the converted procedure with no complications.There was no system/device malfunction prior to procedure conversion.

• Brand Name: DAVINCI SI
• Common Device Name: PATIENT SIDE CART, RECERTIFIED
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 16204274
• Report Number: 2955842-2023-10157
• Device Sequence Number: 5415957
• Product Code: NAY
• UDI-Device Identifier: 00886874110775
• UDI-Public: (01)00886874110775
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2022

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: 380686-04
• Device Catalogue Number: 380686
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Race: American Indian Or Alaskan Native