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

Model Number	48360B-09
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Unspecified Tissue Injury (4559)
Date of Event	08/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the sureform 60 blue reload used in this procedure to perform failure analysis.A sureform 60 stapler has been received; however, the evaluation has not been completed.A review of the stapler logs was performed for this procedure.The sureform 60 stapler instrument was installed on the system eight times and fired eight reloads (six blue, followed by two white).On install 1, the system failed to detect the reload color and the user manually selected the blue reload via the surgeon side console (ssc) touchpad.On each install, the first clamp was successful, and the firings were each completed with no pauses for compression.The instrument was then removed and not used again in the procedure.No stapling issues or errors were observed in the logs.
Event or Problem Description
It was reported that during a da vinci-assisted gastric bypass surgical procedure, an incomplete staple line using a sureform 60 stapler instrument with a blue reload was observed.The customer reported bleeding that required additional suturing.The procedure was completed as planned.
Additional Manufacturer Narrative
Updated fields: b2, annex codes e, f and b.Additional information: intuitive surgical, inc.(isi) did not receive the blue reload involved with the event but did receive the sureform 60 stapler instrument to perform failure analysis.The instrument was tested on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.The stapler initialized, clamped, fired, and unclamped without any issues in both attempts.Also based on log review the instrument did not encounter any issues while being used.The instrument was fully functional.No product issue was found.Isi followed up with the initial reporter and obtained the following additional information: a gastric bypass (roux-en-y) surgical procedure was being performed at the time of this event.The amount of blood loss was noted to be approximately 200-300 ml with no blood transfusions administered.It was reported that the sureform 60 stapler instrument fired but did not fully close the clamp and no system errors or clamping issues were observed prior to firing the stapler reload.Fired staples were noted to not be fully closed on one side, however no pictures are available for review.It was reported that there was a gap on one side of the staple line.The intended staple line was not fired over an existing staple line.The area was sutured over.The procedure was completed robotically.The patient has not experienced any complications due to this event, however there is concern for acute abdomen or insufficiency.The patient experienced severe postoperative pain and was required to stay in the hospital two days longer than expected.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 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: 22926810
• Report Number: 2955842-2025-36443
• Device Sequence Number: 18432308
• Product Code: GDW
• UDI-Device Identifier: 10886874113834
• UDI-Public: (01)10886874113834(10)N/A
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 48360B-09
• Device Catalogue Number: 48360B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown