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

Model Number 480460-09

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/08/2024

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the intraoperative complication cannot be determined.No product has been returned to intuitive surgical, inc.For evaluation.A review of the device logs for the sureform 60 stapler instrument associated with this event was performed by an intuitive surgical, inc.(isi) failure analysis engineer (fae).Per the fae, the logs show the instrument was installed on the system 3 times, and it fired 1 blue reload.On installs 1 and 2, the stapler failed to engage with the system.The system logs show 2 instances of error code 22020, with parameters indicating that the grip axis failed to engage.On the third install, the stapler engaged, the first clamp was successful, and the firing was completed with no pauses for compression.The stapler was then removed, and it was not used in the procedure again.There were no additional stapler related errors in the system logs.

Event Description

It was reported that during a da vinci-assisted distal pancreatectomy procedure, the sureform 60 stapler instrument did not work properly, and there was bleeding as a result.Intuitive surgical, inc.(isi) contacted the site for additional information; however, at the time of this report, no further details have been provided.

• 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: 19074662
• MDR Text Key: 339748997
• Report Number: 2955842-2024-13192
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115647
• UDI-Public: (01)10886874115647(10)L87230706
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K173721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480460-09
• Device Catalogue Number: 480460
• Device Lot Number: L87230706 0483
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2023
• 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.