MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; VESSEL SEALER EXTEND

Model Number 480422-01

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

Patient Problems Bowel Burn (1756); Bowel Perforation (2668)

Event Date 01/03/2022

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root cause of the customer reported incident is speculated to be a thermal injury from either a mcs or vse instrument.However, logs indicate that the mcs instrument was used in subsequent procedures.The vse instrument is a single-use instrument, and a review of the site's complaint history shows that no related complaints have been filed against the instrument.It was confirmed by the surgeon that the products will not be returned to isi for evaluation as there was no malfunction that occurred during the procedure.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 system log review has been performed.All of the errors in the logs for the procedure in question are class 0 (system service advisory (no fault reaction)) and class 8 (engineering event informational (no fault reaction)).None of these errors indicate a product issue.This complaint is being reported due to the following conclusion: after a da vinci-assisted transverse colectomy surgical procedure, the patient was identified to have a delayed thermal bowel injury.As a result, the patient underwent a second open surgical procedure to address the bowel injury.The surgeon confirmed there is no report of a malfunction of an isi device or system.However, the surgeon believes the vse instrument might have been a contributing factor to the bowel injury.The patient is reported to be in rehab and recovering well.At this time, the root cause of bowel injury is unclear.This incident is also being reported via mdr with patient identifier #431581 against the mcs instrument that is referenced.Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date is blank because the product is not implantable.Fields pma/510(k) number and adverse event are not applicable.

Event Description

It was reported that three days after a da vinci-assisted transverse colectomy surgical procedure, the patient was identified with a delayed thermal bowel injury.The patient had reportedly complained of post-operative pain.As a result, the patient underwent a second open surgical procedure to address the bowel injury.Intuitive surgical, inc.(isi) contacted the surgeon and obtained the following information.The surgeon stated the initial robotic procedure was completed with no report of an isi instrument or system malfunction.On post-operative (pod) #3, the patient complained of pain and underwent a diagnostic ct scan that indicated a bowel injury.As a result, the patient underwent a second procedure to address the bowel injury.The surgeon identified a hole on the distal transverse colon, likely a thermal injury from the vessel sealer extend (vse) or the monopolar curved scissors (mcs) instrument.The surgeon repaired the bowel by resection and re-anastomosis.The surgeon confirmed the following: there were no adhesions from previous surgeries, no third-party energy instruments were used, no unintended arm movement could have caused the bowel injury, no video recording of the initial procedure, and there was no arcing witnessed and no malfunction of an isi product during the initial procedure.The surgeon indicated that it was a ¿missed bowel injury.¿ as there was no malfunction of an isi product, none of the instruments will be returned to isi for evaluation.The patient was in the icu, now in rehab, and is reported to be recovering well.

• Brand Name: ENDOWRIST
• Type of Device: VESSEL SEALER EXTEND
• 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: 13447523
• MDR Text Key: 285033637
• Report Number: 2955842-2022-10181
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)L91210920
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480422-01
• Device Catalogue Number: 480422
• Device Lot Number: L91210920 0269
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Sex: Male