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

Model Number 48360B-08

Device Problem Use of Device Problem (1670)

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The surgeon attributes the events to reload size selection.There was insufficient information to perform a site history review for the procedure; therefore, no system or instrument logs are available for evaluation.This medwatch report (mfr report number) represents one of the reported sureform 60 blue reload events.A separate medwatch report (mfr report number: 2955842-2024-10944) was submitted for the other reported event.

Event Description

The surgeon reported that during two separate da vinci-assisted surgical procedures approximately 7-8 months ago, a staple line bleed occurred.The procedures were either a hemicolectomy or a small bowel resection.Due to the staple line bleeds the patients required a return to the operating room for a subsequent procedure to address the bleeding.The surgeon attributes the events to inaccurately selecting the appropriate reload for the targeted tissue.A sureform 60 blue reload was used during both events, and the surgeon believes he should have used a white reload.The surgeon could not provide any further specific information regarding the two events.Both patients recovered well.

• Brand Name: SUREFORM
• Type of Device: STAPLER 60 RELOAD BLUE
• 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: 18700687
• MDR Text Key: 335296519
• Report Number: 2955842-2024-10945
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48360B-08
• Device Catalogue Number: 48360B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2023
• 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: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.