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

Model Number	48360G-10
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The sureform 60 green reload accessory was analyzed and the knife was discovered to be dislodged from its track, resulting in becoming lodged in the cartridge.This caused the observed damage to both the cartridge and the knife.Additionally, a thorough examination of the system logs revealed an error message.The failure is frequently attributed to user operation and appeared to associate with the issue reported in the log review: "tissue too thick to continue." this issue may be linked to a dislodged knife.Additional related observation(s): the reload was found to have loose staples stuck in front of the knife.The reload was found to have a damaged blade.The blade exhibited mechanical indentations/burrs.The sureform 60 green reload exhibits physical damage to the reload cartridge.The blade was found to be lodged in the cartridge causing the damage observed.The probable root cause is attributed to loose staples from firing across staple lines or not having a full bundle of tissue between the jaws during use.The probable root cause of reload damage is attributed to high firing torques, which can result from firing on challenging tissue (e.G., tissue condition) or hard objects (e.G., staples).
Event or Problem Description
The sureform 60 green reload was an incidental return with no reported issue.There was no report of patient harm due to this event.
Additional Manufacturer Narrative
The reload was re-evaluated by failure analysis team.The discrepant green reload accessory was analyzed.The reload was found to have the knife exposed within the knife track.The knife was exposed towards the middle of the returned reload.Additionally, a thorough examination of the system logs revealed an error message.The failure is frequently attributed to user operation and appears to be associated with the issue reported in the dsp log review: "tissue too thick to continue." this issue may be linked to a exposed knife where the firing stopped.Additional observation related to the customer-reported event was that the reload was found to have loose staples stuck in front of the knife.The reload was found to have a damaged blade.The blade exhibited mechanical indentations/burrs.The sf 60 green reload exhibits physical damage to the reload cartridge the blade was found to be lodged in the cartridge causing the damage observed.An additional discrepant rma on the stapler (480460-09/k16250206-0431) was also analyzed in failure analysis.The reported event with the instrument could not be replicated nor confirmed.The instrument was placed and driven on the in-house system.The instrument passed initialization.The instrument passed the recognition and engagement tests multiple times.The instrument moved intuitively with full range of motion in all directions.The jaws opened and closed properly.The instrument clamped, fired, and unclamped successfully.The instrument was successfully fired with a sf 60 black reload.Visual inspection was performed and no damage was observed.Additionally, the instrument logs were thoroughly examined, indicating no instances of engagement, initialization or recognition failures associated with the instrument.The instrument was fully functional.No product issue was found.The complaint was confirmed by failure analysis on the returned green reload.A review of the advanced stapler log review was completed.Logs show pn 480460-09, ln k16250206-0431, was installed on the system 4x and fired 3 reloads (2 green, followed by 1 blue).On installs 1-3, the first clamps were successful, but followed by firing failures in each case.All firings stopped at ~49% completion.On install 4, a green reload was installed, however no clamping or firing was attempted.The instrument was then removed and not used again in the procedure.Next, logs show pn 480460-09, ln k16250206-0432, was installed on the system 5x and fired 4 reloads (1 green, followed by 3 blue).On install 1, the first clamp was successful, and the firing was completed with 5 pauses for compression.On installs 2, 3, and 5, the first clamps were successful, and the firings were each completed with no pauses for compression.On install 4, a blue reload was installed, however no clamping or firing was attempted.The instrument was then removed and not used again in the procedure.There were no additional errors in the msc logs pertaining to the staplers.The probable root cause of the exposed knife based on the failure analysis findings is attributed to instrument damage, particularly in the wrist area, tissue condition (e.G., disease state and density), and foreign objects (e.G., metal clips) that can cause stapler firing forces to exceed the prescribed limit and subsequently result in a partial fire.The probable root cause of the loose staples can be attributed to damage during use/handling, such as high loads on the knife.The probable root cause of the blade damage is attributed to the exposed knife observed.
Event or Problem Description
Refer to 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: 24849326
• Report Number: 2955842-2026-21086
• Device Sequence Number: 8947162
• Product Code: GDW
• UDI-Device Identifier: 10886874113841
• UDI-Public: (01)10886874113841(10)NA
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48360G-10
• Device Catalogue Number: 48360G
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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