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

Model Number	48360G-09
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted revision gastric bypass reversal procedure, the stomach tissue slipped while firing, causing an incomplete staple line.The issue occurred on the first fire while using a sureform 60 stapler instrument with a green reload accessory; tissue was pushed forward, partially stapled and cut in different areas, without stapling.There were no malformed or unformed staples observed and the reload did not have an exposed blade.The procedure was converted to laparoscopy due to the holes/gaps, which required the surgeon to remove additional tissue from the gastric pouch.As a result, the anastomosis was modified from a linear to a circular anastomosis, which put the patient at a higher risk for complications post-operatively.The procedure was completed and there were no post-operative complications.
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 sureform 60 stapler instrument or the green reload accessory that was used during this reported event; therefore, failure analysis investigations could not be performed.Advance stapler log review showed the sureform 60 stapler instrument was installed on the system 5 times and successfully fired 5 reloads (1 white, 1 green, 3 white, in that order).There were no stapler related errors in the logs.
Additional Manufacturer Narrative
Intuitive surgical, inc.Did receive the sureform 60 green reload accessory to perform failure analysis and did not confirm or replicate the customer reported complaint.Visual inspection found all the pushers deployed and all staples discharged.Additionally, the reload was found to have the knife exposed within the knife track.The knife was exposed towards the distal end of the returned reload.The reload was found to have blade damage.The accessory reload knife was found to have mechanical indentations.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 RELOAD GREEN
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 20247988
• Report Number: 2955842-2024-19533
• Device Sequence Number: 20673433
• Product Code: GDW
• UDI-Device Identifier: 10886874113841
• UDI-Public: (01)10886874113841(10)K10240222
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K173721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: 48360G-09
• Device Catalogue Number: 48360G
• Device Lot Number: K10240222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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: ISIFA2022-02-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose