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

Model Number 480460-09

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 08/24/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation is in progress to determine the cause of this reported event.Additional information is being gathered to determine the contribution of the device to the customer reported issue.The investigation to determine the cause of this reported event is currently in progress.As such, the probable root cause cannot yet be determined based on the information provided.

Event Description

It was reported that during a da vinci-assisted sleeve gastrectomy surgical procedure, the customer reported the sureform 60 stapler malfunctioned.Anytime the surgeon would change position of their fingers the stapler would unclamp when trying to clamp.Customer opened a new stapler which worked fine.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and confirmed that the instrument all looked good until they observed the issue.The surgeon was trying to clamp, and the sureform 60 stapler kept unclamping.They decided to open another stapler to complete the procedure.No patient harm and no incomplete staple due to the issue.No patient demographic information available.

• Brand Name: SUREFORM
• Type of Device: STAPLER 60
• 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: 17796400
• MDR Text Key: 324015534
• Report Number: 2955842-2023-18651
• Device Sequence Number: 1
• Product Code: NAY
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480460-09
• Device Catalogue Number: 480460
• Device Lot Number: K11230413
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• Is the Device Single Use?: Yes
• 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.