MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; 8MM STAPLER

Model Number	48230B-06
Medical Device Problem Codes	Unintended Ejection (1234); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive the sureform 30 stapler blue reload to perform failure analysis (fa).Fa was not able to confirm nor reproduce the reported complaint.The reload was returned with the orange installation tool and the yellow removal tool detached.No damage to the installation tools was observed.The installation tool was installed onto the reload without any issues.The reload was returned unused and unfired.The probable root cause of the customer-reported event could not be established due to fa not being able to confirm/replicate the alleged event.Additional observations not reported by site: the reload was found to have missing staples.Due to the missing staples, detached fragments were observed.The reload was transferred to a failure analysis engineer (fae) for further investigation: fae confirmed initial fa findings.The installation tool and removal tool were detached from the reload upon return.Both were re-installed and removed from the reload without issue.Investigation was unable to confirm nor replicate the event.It was additionally observed that the reload was returned with missing staples.Specifically, the three most proximal staples on the left side of the cartridge were absent from their designated pockets.It is likely that the reload was improperly aligned within the channel during the reload installation process.It is also likely that the installation tool was not used.The cartridge was designed to have its two halves inserted on either side of the knife track.However, if the alignment within the channel is incorrect or if extreme angles of insertion are used, interaction with the channel or knife track may result in a partial deployment of proximal pushers.The missing staples are attributed to use conditions.Proper use of the installation tool ensures correct alignment of the reload within the instrument channel and prevents staples from deploying prematurely.The probable root cause of the missing staples observed may be attributed to, according to failure analysis, improper usage - possible incorrect alignment of the reload within the instrument channel may cause staples to deploy prematurely.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.
Event or Problem Description
It was reported that during a da vinci-assisted pancreatoduodenectomy surgical procedure, the sureform 30 stapler blue reload disengaged from the installation tool prior to installing the reload onto the reload channel.No fragment fell inside the patient.No known impact or patient consequence was reported.

• Brand Name: SUREFORM
• Common Device Name: 8MM STAPLER
• 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: 22731634
• Report Number: 2955842-2025-33086
• Device Sequence Number: 8990143
• Product Code: GDW
• UDI-Device Identifier: 10886874121914
• UDI-Public: (01)10886874121914(10)U10250401
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K211997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48230B-06
• Device Catalogue Number: 48230B
• Device Lot Number: U10250401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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