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

Model Number 48360

Device Problem Use of Device Problem (1670)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 07/31/2023

Event Type  Injury  

Event Description

It was reported that while stapling the stomach during a da vinci-assisted sleeve gastrectomy, the end of the bougie was inadvertently stapled along with the tissue.The staple line was revised to free the bougie and the procedure was completed robotically.

Manufacturer Narrative

Based on the current information provided, the cause of the surgeon inadvertently stapling the end of the bougie is unknown.However, it was confirmed with the robotics coordinator that the event was not the result of an intuitive surgical, inc.(isi) product malfunction.The sureform 60 instrument and reload are confirmed to have been discarded and are not available for failure analysis.Advanced stapler logs show the sureform 60 instrument was installed on the system 6 times and fired 6 reloads (2 green, followed by 4 blue).On each install the first clamp was successful and the firing was completed.On installs 1, 2, 3, and 5, the firings were completed with 1 pause for compression on each.For installs 4 and 6, the firings were completed with no pauses for compression.There were no incomplete clamps, incomplete unclamps, or firing failures for this instrument, per the logs.There were no errors in the system logs.A system log review did not reveal any system errors that would have caused or contributed to the reported event.

• Brand Name: SUREFORM
• Type of Device: STAPLER 60 RELOAD
• 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: 17657742
• MDR Text Key: 322362260
• Report Number: 2955842-2023-18129
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 48360
• Device Catalogue Number: 48360
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2023
• 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: ISIFA2023-04-R
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.