MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; STAPLER 60 RELOAD GREEN

Model Number 48360G-06

Device Problems Failure to Cut (2587); Failure to Fire (2610)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 12/14/2023

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted sleeve gastrectomy surgical procedure, tissue was dragged when a green sureform 60 reload was fired with a sureform 60 stapler instrument.On the first fire, the surgeon successfully fired a black stapler reload on stomach tissue with no issues.On the second fire, upon firing the stapler, the blade started dragging the tissue instead of cutting through it.The surgeon hit the emergency stop button and removed the stapler.The green stapler reload had fired around 10mm or less than a quarter of the way; the staples deployed were fully formed, but not deployed into the tissue.There was a small amount of bleeding which the surgeon stated was not clinically important; and a bipolar forceps instrument was used for coagulation.A blue stapler reload was then used to finish the staple line, and a small amount of additional tissue needed to be removed due to the firing failure; but the surgeon stated it was not clinically important.The stapler was used for the remainder of the procedure with no further issues.The procedure was completed robotically.The surgeon stated there was no harm to the patient and there were no post operative complications.

Manufacturer Narrative

Based on the information provided, the cause of the reported complication cannot be determined.The stapler reload was reportedly disposed; therefore, failure analysis cannot be performed.The logs show the sureform 60 stapler instrument was installed on the system eight times and fired seven reloads (1 black, 1 green, 5 blue, in that order).On each install except for the third install, the first clamp was successful and the firings were each completed with no pauses for compression.On the second install, the clamp was initiated but the logs show the emergency stop button was pressed twice during the procedure by the user on surgeon side console (ssc) #1.The firing was then initiated and completed to 100% completion, per the logs.The instrument was then unclamped and installed a fourth time.On install four, a blue stapler reload was loaded, however no clamping or firing was performed.After the seventh fire, the instrument was removed and not used in the procedure again.There were no additional stapler related errors in the logs.

• Brand Name: SUREFORM
• Type of Device: STAPLER 60 RELOAD GREEN
• 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: 18489102
• MDR Text Key: 332602505
• Report Number: 2955842-2023-21827
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48360G-06
• Device Catalogue Number: 48360G
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: ISIFA2022-02-C
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Female