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

Model Number	48360W-08
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, the cause of the reported complication cannot be determined.Intuitive surgical, inc.(isi) did not receive the white reload used during this reported event for failure analysis investigations.Sureform 60 stapler instrument logs show the first stapler was installed on the system 5x and fired 5 reloads (1 blue, followed by 4 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.The second sureform 60 stapler was installed on the system 1x and fired 1 white reload.The first clamp was successful, and the firing was completed with 1 pause for compression.The instrument was then removed and not used in the procedure again.There were no errors in the logs pertaining to these staplers.Report with patient identifier (b)(6) documents the blue reload.
Event or Problem Description
It was reported that during a da vinci-assisted gastric bypass surgical procedure, the staple line leaked.It was reported the sureform 60 stapler instrument fired with multiple white reloads and a blue reload, when a leak test was performed it showed multiple leaks within the staple line on stomach tissue and small bowel.To address the leak the surgeon imbricated the entire pouch, stomach and small bowel with running suture, adding an additional hour and thirty minutes to the procedure.There were no reported errors with the sureform 60 stapler instrument or the multiple reloads, no tissue push events, and no malformed staples were produced.The surgeon noted the entire staple line looked complete, but during the leak test it was then noticed the staple line was leaking, no significant bleeding occurred.No additional tissue resection was required, no buttress material was used.The procedure was completed robotically with no further events.A drain was placed intraoperatively due to the additional suture and was removed with no issues on postoperative day eight.The patient stayed an additional day in the hospital, but there have not been any complications postoperatively.

• 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: 18631664
• Report Number: 2955842-2024-10917
• Device Sequence Number: 7725535
• Product Code: GDW
• UDI-Device Identifier: 10886874113827
• UDI-Public: (01)10886874113827(10)K10230322
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 01/04/2024

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-08
• Device Catalogue Number: 48360W
• Device Lot Number: K10230322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2023
• 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 Age: 27 YR
• Patient Sex: Female
• Patient Weight: 170 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American