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

Model Number	48230W-06
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the da vinci product with an alleged issue to perform failure analysis.Visual inspection found that the reload switch was dislodged from the reload tail.The dislodged switch was returned with the reload.The reload was found to have a detached fragment.The reload switch became dislodged from the tail of the reload.The switch was returned.The root cause of this failure is attributed to user.The reload was found to have cartridge damage.The damage was found at the proximal end near the reload tail.There was no material missing.The reload was found to have staples missing from the reload pockets at the proximal end.The reload was missing a total of twelve staples.This failure typically occurs when an attempt is made to install the reload into the instrument jaws without using the installation tool.The root cause of this failure is attributed to mishandling/misuse.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary segmentectomy surgical procedure, the endowrist 30 white reload had a piece of metal that was attached to the base break off when the customer was attempting to attach it to the instrument.The user completed the procedure with no further issue reported.No fragment fell inside the patient.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive followed up and obtained additional information.No fragment fell inside the patient.There was no patient injury.No patient demographic information was available.No images or video recordings available for review.Initial findings were confirmed.The reload was returned with a dislodged switch.The switch was dislodged from the tail but was returned with the reload.The reload was also observed with minor cartridge damage to the area of the tail that connects to the rest of the reload body.The reload was also observed to be missing staples from the proximal end of the reload.7 of the most proximal staples were missing from the left side of the cartridge, while 4 of the most proximal staples were missing from the right side of the cartridge.The probable root cause of the reported complaint can be attributed to an improper reload installation.This can happen during the reload installation process when the installation tool was not used or became separated from the reload body during the process.This may result in improper alignment of the reload tail within the instrument channel.Proper use of the installation tool ensures correct alignment of the reload within the instrument channel and prevents staples from deploying prematurely or damage to the reload components.This issue can be resolved by using an alternate reload to complete the procedure.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 22948721
• Report Number: 2955842-2025-36097
• Device Sequence Number: 8260390
• Product Code: NAY
• UDI-Device Identifier: 10886874121921
• UDI-Public: (01)10886874121921(10)K13241031
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K211997
• 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): 08/07/2025

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: 48230W-06
• Device Catalogue Number: 48230W
• Device Lot Number: K13241031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 09/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• 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