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	08/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) failure analysis engineer (fae) reviewed the stapler logs for the stapler used in this event and the following info was provided: the logs show a sureform 60 stapler instrument (part #480460-09, lot #t11230323-0169) was installed on the system 8 times and fired 5 stapler reloads (1 blue, followed by 4 white).On installs 1, 4, and 5, no clamping or firing was attempted.On installs 2, 3, 6, and 7, the first clamp was successful, and the firings were each completed with 1 pause for compression.On install 8, the first 2 clamp attempts were aborted by the user at approximately 69% and 93% completion.The 3rd 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 stapler related errors in the logs.
Event or Problem Description
It was reported that during a da vinci-assisted sleeve gastrectomy surgical procedure, the sureform 60 stapler instrument got stuck on stomach tissue after firing a white sureform 60 reload.At least three unformed and undeployed staples on the white sureform 60 reload caused tissue to be stuck to the stapler reload.The system did not display any errors/messages during the event.In order to safely remove the stapler instrument, the tissue was transected from the stapler reload.This caused a less than 15 minute delay in the case.There were no holes/gaps on the staple line.There were no obstructions, existing staple lines, or buttress material in the path of the stapler instrument.The procedure was completed robotically with the same sureform 60 stapler instrument.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The sureform 60 stapler instrument used with the reload was analyzed by the failure analysis team and the findings did not replicate or confirm the customer reported event.The stapler was fully functional.No product issue was found.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 RELOAD WHITE
• 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: 20295515
• Report Number: 2955842-2024-19606
• Device Sequence Number: 7209312
• Product Code: GDW
• UDI-Device Identifier: 10886874113827
• UDI-Public: (01)10886874113827(10)NA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose