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

Model Number 48360B

Device Problems Failure to Cut (2587); Failure to Fire (2610)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 02/21/2024

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted sleeve gastrectomy surgical procedure, the blue reload failed to fire staples causing a tissue pushout, requiring intervention.The tissue pushout event occurred on stomach tissue with a blue reload without buttress material on the 3rd or 4th fire of the sureform 60 stapler instrument.The stapler compressed as normal and no error messages that occurred during the fire.The surgeon saw the stapler start firing and the blade lost traction of the tissue which caused the tissue to push out of the jaws shredding the stomach tissue.There were no dumped staples, the staple line was not aligned, and the tissue was bleeding, approximately 100ml.The surgeon then opened a new sureform 60 stapler instrument, and a new reload was used to resect additional tissue.The new reload was positioned higher up on the stomach closer to the bougie than expected and the surgeon was able to successfully resect the damaged tissue.The surgeon then sutured the additional defect closed.A leak test was performed with no complications.The initial stapler was working without issue before the event.The procedure was completed robotically.The patient is recovering as expected, with no postoperative complications.

Manufacturer Narrative

Based on the information provided, the cause of the reported complication cannot be determined.The first sureform 60 stapler instrument log show (part number: 480460-09), (lot number: k13230727-0072), was installed on the system 4x and fired 4 reloads (1 black, 2 green, 1 blue, in that order).On each install the first clamp attempt was successful.The first firing was completed with 1 pause for compression, and firings 2-4 were completed with no pauses for compression.The instrument was removed and not used in the procedure again.There were no stapler related errors in the logs.Next, the second sureform 60 stapler instrument logs show (part number: 480460-09), (lot number: k13230803-0448), was installed on the system 3x and fired 3 reloads (1 green, 1 blue, 1 white, in that order).On each install, the first clamp was successful, and the firings were each completed with no pauses for compression.The instrument was removed and not used in the procedure again.There were no stapler related errors in the logs.A review of the provided images was performed by an intuitive surgical, inc.(isi) cde.The following additional information was provided: the images provided show multiple staple lines on stomach tissue, with at least a portion of one of the staple lines incompletely formed and with several malformed staples.There is an amount of blood pooled at the bottom of the surgical scene.The images do appear to be consistent with tissue pushout.Tissue pushout events are commonly attributed to stapling across an existing staple line.

• 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: 18918933
• MDR Text Key: 337844689
• Report Number: 2955842-2024-12214
• 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
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2024
• 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: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• 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: ISIFA2022-02-C
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.