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

Model Number 48360B

Device Problem Retraction Problem (1536)

Patient Problem Laceration(s) (1946)

Event Date 12/12/2023

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the intraoperative complication cannot be determined.The product has not been returned to intuitive surgical, inc.(isi) for evaluation.The system is programmed to display a warning message stating, ¿blade may be exposed¿ and a warning tone.The warning is intended to provide the bedside assistant information to proceed with caution when handling the instrument.The impact to the patient presented by this event is low, as the surgeon is able to quickly detect the failure.The surgeon has visibility of this failure in multiple ways: 1.If a dislodged blade occurs, an error message is shown on the surgeon console and the patient side cart monitors, indicating an exposed blade.2.If the blade has dislodged and is unable to retract back into the instrument grips, the system will no longer allow the user to attempt to extend the blade.A review of the advanced instrument log for the sureform 60 stapler instrument likely associated with this event was performed by an isi failure analysis engineer (fae).Per the fae, the logs show the instrument was installed on the system 9 times, and it fired 7 reloads (5 blue, 1 black, 1 white, in that order).On install 1, the first clamp was successful, and the firing was completed with 1 pause for compression.On install 2, the first clamp was aborted by the user at ~65% completion.The next clamp was successful, and the firing was completed with no pauses for compression.On install 3, the first clamp was successful, and the firing was completed with no pauses for compression.On install 4, the first clamp was aborted by the user at ~37% completion.The next clamp was successful, and the firing was completed with no pauses for compression.On install 5, the first clamp was successful, and the firing was completed with no pauses for compression.On install 6, the first clamp was incomplete, stopping at ~43% completion.The next clamp was aborted by the user at an unknown completion percentage, due to pressing the unclamp pedal around the same time.No firing was attempted.On installs 7 and 8, the user was prompted to manually select the reload color, due to not firing on the previous installs.On install 7, there were 4 incomplete clamp attempts, each stopping at ~55% completion.No firing was attempted.On install 8, the first clamp was incomplete, stopping at ~57% completion.The next clamp was successful, and the firing was completed with 1 pause for compression.On install 9, the first clamp was successful, and the firing was completed with no pauses for compression.The instrument was then removed, and it was not used in the procedure again.There were no stapler related errors in the system logs.

Event Description

It was reported that during a da vinci-assisted procedure, the blade of the blue sureform 60 stapler reload failed to return to its proper position, and a nurse sustained an unspecified injury 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 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: 18489410
• MDR Text Key: 332601794
• Report Number: 2955842-2023-22003
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K173721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/12/2023

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: 48360B
• Device Catalogue Number: 48360B
• Device Lot Number: K12230413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2023
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES