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

Model Number	48230B-06
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
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 a da vinci product to perform failure analysis.The stapler 30 blue reload was analyzed, and the findings did not replicate or confirm the customer reported event.The reported event with the accessory could not be replicated nor confirmed.Upon visual inspection, the reload appeared to be unused and unfired.The reload was installed successfully with an in-house instrument when placed on an in-house system multiple time.Additional observation not reported by site: visual inspection was performed and the reload was found to have missing staples at the proximal end.Confirmed initial findings.Installation difficulties could not be replicated through in-house testing.It was observed that the reload was returned with missing staples.No damage to the cartridge material was observed.The reload was not fired.Based on the missing staples at the proximal end, it is likely that during the reload installation process the installation tool was not used or became separated from the reload body during the process.This likely resulted in improper alignment of the reload tail within the instrument channel.The cartridge is design to have its two halves inserted on either side of the knife track.However, if the alignment within the channel is incorrect or if extremely angles of insertion are used, interaction with the channel or knife track of the instrument may result in a partial deployment of proximal pushers.
Event or Problem Description
It was reported that during a da vinci-assisted appendectomy surgical procedure, the stapler 30 blue reload accessory did not load correctly onto a stapler.The procedure was completed with no reported injury.

• 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: 22651966
• Report Number: 2955842-2025-31813
• Device Sequence Number: 18312192
• Product Code: GDW
• UDI-Device Identifier: 10886874121914
• UDI-Public: (01)10886874121914(10)K11250220
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2025

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: K11250220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 07/29/2025
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown