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

Model Number	48360W-09
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An rma was not issued for return as the customer reported that the instrument was disposed; therefore, failure analysis cannot be performed.The logs show for product number: 480460-09, lot number: l87230615-0473, was installed on the system three times and fired three reloads (2 blue, followed by 1 white).On each install, the first clamp was successful, and the firings were each completed with no pauses for compression.The instrument was then removed and not used in the procedure again.There were no stapler related errors in the msc logs.
Event or Problem Description
It was reported that after a da vinci-assisted right hemicolectomy, the patient experienced a staple line bleed.The surgeon stated their technique for the procedure has not changed.The surgeon said they perform an intracorporeal anastomosis using the sureform 60 stapler instrument.Then, two sureform 60 blue reloads are used to divide the bowel.A sureform 60 white reload is used for the side-to-side anastomosis.After the completion of the fire, the staple line is confirmed to be in good condition.The surgeon checks the entire abdomen for any bleeding; the patient is then closed, and the procedure was completed.Post-op day 1, the patient developed a major bleed; the patient's hemoglobin had dropped from 15 g/dl to 7g/dl and was experiencing bloody stools.The surgeon believed this was a result of a staple line leak from the side-to-side anastomosis.The patient was given a blood transfusion, requiring additional hospitalization for observation.The patient was later discharged home.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 RELOAD WHITE
• 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: 18308023
• Report Number: 2955842-2023-21074
• Device Sequence Number: 6717915
• Product Code: GDW
• UDI-Device Identifier: 10886874113827
• UDI-Public: (01)10886874113827(10)N/A
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48360W-09
• Device Catalogue Number: 48360W
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Sex: Unknown