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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the sureform 60 stapler instrument associated with this complaint.A visual inspection displayed no signs of physical damage.The channel sprang back open when in the unclamped state.The instrument was placed on the in-house system and was found to be locked.The instrument generated the following error message: "instrument failure.Manual stapler release previously used on device.Do not reuse." it is an expected condition for the instrument to not operate properly and to receive a lockout error after the manual grip release has been used.The rfid editor was used to unlock the instrument.The instrument was reinstalled on the in-house system and passed recognition and engagement test on 3 of 3 attempts.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.The instrument successfully clamped, fired and unclamped.There was no problem detected.
Event or Problem Description
It was reported that during a da vinci-assisted gastric bypass (roux-en-y) procedure, the jaws of a sureform 60 stapler jaws would not open after a firing sequence with green sureform 60 reload.The emergency stop (e-stop) button was pressed, and the release knob was used to successfully release the stapler's jaws.Bleeding was noted from the staple line while attempting to release the stapler instrument.The following information is unknown: what specific tissue was involved with the staple line bleed, the estimated blood loss from the complication, and what medical/surgical intervention (if any) was rendered due to the bleeding.No additional tissue resection was required.A backup stapler instrument was used for the remainder of the procedure which was completed robotically.The patient was reportedly recovering well.Intuitive surgical, inc.(isi) has attempted to gather additional information regarding the reported event; however, no response has been received.
Additional Manufacturer Narrative
Device evaluation: intuitive surgical inc.(isi) received the sureform 60 green reload associated with this complaint.There was no damage to the reload.There were no device related failures.The reload was returned used and fired.Visual inspection displayed no signs of physical damage to the cartridge, knife, pushers, or cover.The knife had shifted out of the completion position and was in the middle of the reload.The yellow pushers had been deployed throughout the entire reload, which confirms that it progressed through the full firing trajectory.No product issue was identified.
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: 23497176
• Report Number: 2955842-2025-44286
• Device Sequence Number: 15715573
• Product Code: GDW
• UDI-Device Identifier: 10886874113841
• UDI-Public: (01)10886874113841(10)K11250814
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 12/05/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 48360G-10
• Device Catalogue Number: 48360G
• Device Lot Number: K11250814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 124 KG
• Patient Ethnicity: Non Hispanic