MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MEDIUM-LARGE CLIP APPLIER

Model Number 470327-12

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 01/21/2022

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided and upon review by the customer of the procedure video, the cause of the intra-operative complication can be attributed to use-error as the assistant surgeon punctured the portal vein with a 3rd-party forceps instrument.As the surgeon was trying to control bleeding with gauze, a previously placed clip on the portal vein was knocked off which led to excessive bleeding.The site declined to return any da vinci products as there was no allegation of a malfunction of a da vinci system, instrument, or accessory.If additional information is received, a follow-up mdr will be submitted.As of 25-jan-2022, a review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the system and instrument logs has been performed.There were no observed events in the available system logs that would suggest a product issue, and logged events are in line with normal system functionality.Although none of the reusable instruments were reused in subsequent procedures, a site review shows no complaint filed against the instruments.The logs were also reviewed by an intuitive surgical, inc.(isi) advanced failure analysis engineer (fae) and there were no errors recorded in the logs during the usage of the vessel sealer extend (vse) instrument.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: during a da vinci-assisted pancreatic duodenectomy procedure, the case was converted to a "small incision" in order to perform the pancreatic jejunal reconstruction outside of the patient's body.At that time, the robot was undocked from the patient.However, after the robot was undocked, an assistant surgeon punctured the portal vein with a 3rd-party forceps instrument which resulted with bleeding.Also, during attempts to control bleeding, a previously placed clip on a vessel became dislodged resulting with excessive bleeding.The procedure was then converted to open surgery to achieve hemostasis.The vein was sutured to achieve hemostasis and the patient was transfused with blood.The procedure was completed via open surgery.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.There is also no allegation that a da vinci product caused or contributed to the operative complication.

Event Description

It was reported that during a da vinci-assisted pancreatic duodenectomy procedure, the procedure was converted to a small incision technique due to a long procedure time during the pancreatic jejunal reconstruction.The long procedure time was due to lack of surgeon's experience and the complexity of the procedure.There was no particular issue in the anatomy although the pancreas was big, and the vessels had many branches.The system was undocked during the conversion of the procedure to a ¿small incision¿ and 3rd party instruments were utilized.Upon the site's review of the procedure video, it was noted that during the ¿small incision¿ part of the procedure, the assistant doctor punctured the portal vein with a 3rd party forceps instrument resulting in heavy bleeding.The procedure was converted to open to stop the bleeding.During efforts to stop the bleeding with gauze, a previously placed clip was dislodged.It is unclear if the clip was placed during the robotic surgery or after the procedure was converted to a "small incision." according to the surgeon, the long duration of the surgery also caused the levels of the platelet to drop resulting with difficulty stopping the bleeding.The surgeon performed suctioning and sutured the bleeding point to achieve hemostasis.The amount of bleeding was 6l.The surgeon used hem-o-lock clips and third-party "ds" clips during the procedure.The clips were applied around the portal vein and its branches.There were no issues upon application of the clips with the da vinci medium-large clip applier instrument nor any loose cables seen on the instrument.The clips were applied properly, and the size of the blood vessels clipped were greater than 3 mm.There was no unexpected movement of the clip applier instrument during clip application.The third-party clip application is dependent upon the grip strength of the assistant.The surgeon stated that there were no da vinci product issues and that the intra-operative complications were not related to da vinci.The site declined to return the medium-large clip applier instrument back for failure analysis as the surgeon felt that the cause of the incident was not due to any da vinci instruments.

• Brand Name: ENDOWRIST
• Type of Device: MEDIUM-LARGE CLIP APPLIER
• 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: 13559630
• MDR Text Key: 290528101
• Report Number: 2955842-2022-10281
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112465
• UDI-Public: (01)00886874112465(11)210318(10)N10210322
• 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: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 470327-12
• Device Catalogue Number: 470327
• Device Lot Number: N10210322 0156
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2021
• 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