MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; PATIENT SIDE CART, 4-ARM

Model Number 380652-37

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Vascular Dissection (3160)

Event Date 12/08/2021

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted total hysterectomy, while the surgeon was performing tissue dissection adjacent to the kidney, the renal artery was accidentally damaged with an unspecified da vinci instrument.As a result, the procedure was converted to laparoscopic surgery.A urologist was called in, and the surgeon removed the ipsilateral kidney with the damaged renal artery laparoscopically.The following were confirmed: there was no unintentional robotic arm movement, no collision of instruments, and the patient is reported to be recovering well.The description of the injury on the renal artery was that it was ¿transected.¿ no malfunction of any da vinci instruments was observed when the vessel injury occurred.The following are unknown: the cause of the reported issue, what da vinci instrument was in use when the vessel injury occurred, the estimated blood loss, if any blood transfusion was rendered to the patient, the details of the vessel repair, and the sequence of events that led to the unplanned nephrectomy.

Manufacturer Narrative

Based on the current information provided, the cause of the intra-operative complication is unknown.Intuitive surgical, inc.(isi) has requested if the da vinci instrument used when the vessel injury occurred will be returned for failure analysis investigation; however, the site stated that there was no allegation that a malfunction of the isi instrument occurred; hence, none of the instruments will be returned to isi for evaluation.If additional information is received, a follow-up mdr will be submitted.No image or video clip for the reported event was submitted for review.A review of the site's complaint history does not reveal any additional complaints related to this event.A review of the site's system logs for the reported procedure date was completed.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.Additionally, all instruments used in the case were used in subsequent procedures, with the exception of the following: vessel sealer instrument, which is a single-use instrument, and site reviews have shown that no complaints were filed against the instrument.This complaint is considered a reportable event due to the following conclusion: during a da vinci-assisted surgical procedure, the renal artery was accidentally injured by the surgeon.As a result, the kidney was removed.Although the site has confirmed no malfunction of a da vinci instrument was observed during the event; a da vinci instrument was in use when the renal artery was injured, resulting in an unplanned nephrectomy.The cause of the renal artery injury is unknown.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• 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: 13227795
• MDR Text Key: 288905455
• Report Number: 2955842-2022-10034
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/14/2021

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
• Device Operator: Health Professional
• Device Model Number: 380652-37
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Female