MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; SUREFORM 45 RELOAD BLUE

Model Number	48345B-03
Medical Device Problem Codes	Material Fragmentation (1261); Firing Problem (4011)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The blue sureform 60 reload has not been received for failure analysis evaluation.
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy procedure, the customer went to clamp and fire a blue sureform 60 reload with a sureform 60 stapler instrument.The surgeon stated that staples went everywhere, no transection happened, and a blue fragment was found in the patient's abdomen.The fragment was retrieved during the same surgical procedure and a new stapler instrument was introduced.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
On 30-jun-2025, intuitive surgical, inc.(isi) received user facility report (b)(4) stating: "misfire on the 7th fire".Additional information was obtained from the customer: during a wedge resection for a gastric pouch using a da vinci system, a stapling stomach tissue, issue occurred with a sureform blue reload.This was the seventh fire, and the stapler initially worked correctly but then misfired, causing tissue to be pushed forward and injured.Malformed staples were noted, with about 1/4 of the staple line firing correctly before misfiring.Then all rows misfired with staples themselves being everted and did not penetrate into tissue, the tissue then got dragged and injured in this process.A plastic piece from the stapler load broke off and had to be removed.No error messages were generated, and no obstructions or pre-existing staple lines were encountered.There was no bleeding or clamping issues observed.Unplanned tissue removal was performed to prevent post-surgical leaks, resulting in a successful outcome.The procedure was completed robotically using a backup isi stapler.Both the reload and instrument were returned to isi for evaluation, but no photographic images or video recordings are available for review.The sureform reload and stapler have been received for failure analysis evaluation.However, the failure analysis investigation has not been completed at the time of this report.
Additional Manufacturer Narrative
Device evaluation: the blue sureform 45 reload and stapler instrument has been returned and evaluated by the failure analysis team on 08/20/2025.The blue sureform 45 reload was analyzed and there are no device related failures.The reload was returned unused and unfired.It was proceeded with the instrument.Visual inspection displayed no signs of physical damage to the cartridge, knife, pushers, or cover.The reload was attached to an in-house golden instrument and placed and driven on an in-house system.The reload attached to and removed from the instrument without any issues on multiple attempts.The instrument passed the recognition and engagement tests.The instrument initialized, clamped, fired, and unclamped without any issues using the returned reload.The reload cover was removed and inspected after firing.There was no damage to the reload or its components.No product issue was identified.Sureform stapler 45 instrument was also analyzed and visual inspection displayed no signs of physical damage.The instrument was fully functional.There was no problem detected.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD BLUE
• 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: 22437746
• Report Number: 2955842-2025-28155
• Device Sequence Number: 11554387
• Product Code: GDW
• UDI-Device Identifier: 10886874117085
• UDI-Public: (01)10886874117085(10)K10250220
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K183224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48345B-03
• Device Catalogue Number: 48345B
• Device Lot Number: K10250220
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 07/22/2025; 08/20/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/15/2025; 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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: 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 Age: 34 YR
• Patient Sex: Female
• Patient Weight: 127 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White