MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MARYLAND BIPOLAR FORCEPS

Model Number 471172-17

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/14/2023

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted total hysterectomy procedure, bleeding occurred from the left uterine artery while vaginal transection on the left side was being performed.Hemostasis was achieved with a maryland bipolar forceps instrument, but bleeding occurred from the right uterine artery during subsequent dissection on the right side.The surgeon attempted to stop the bleeding; however, additional bleeding occurred from the left uterine artery.The surgeon decided to convert the procedure to a small laparotomy (8 cm), due to the risk of further bleeding.It is unclear if hemostasis was not achieved with the maryland bipolar forceps instrument, or if another instrument interfered and touched the point of hemostasis.The total blood loss during the conversion to open was around 500 - 600 ml, including the water supply from the irrigation.Intuitive surgical, inc.(isi) contacted a physician from the site and obtained the following additional information regarding the reported event: the event occurred towards the end of the surgical procedure.When bleeding occurred from the right uterine artery, the surgeon attempted to achieve hemostasis using the maryland bipolar forceps instrument.The physician believes the bleeding was caused by inadequate "treatment of the uterine artery before dissection of the vaginal stump" and the hemostasis was not completely achieved using the bipolar forceps instrument.The physician does not believe a malfunction of a da vinci device caused or contributed to the bleeding.The physician believes anatomical factors caused/contributed to the bleeding.The physician explained that the course of the uterine artery was different from the pattern and the blood vessel being treated was not the main vessel, but a branch.Cautery via open surgery was performed to control/resolve the bleeding.No blood transfusions were provided.The patient tolerated the conversion to open surgery and did not experience any post-operative complications.The patient was discharged.

Manufacturer Narrative

Based on the current information provided, the cause of the intraoperative complication cannot be determined.No product has been returned to intuitive surgical, inc.(isi) for evaluation.Per a review of the site's system logs for the reported procedure date, no related system errors occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.

• Brand Name: ENDOWRIST
• Type of Device: MARYLAND BIPOLAR FORCEPS
• 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: 18311635
• MDR Text Key: 330290494
• Report Number: 2955842-2023-21020
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(10)K12230205
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K214095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/14/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 471172-17
• Device Catalogue Number: 471172
• Device Lot Number: K12230205 0047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2023
• 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