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

Model Number	48230W-06
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary segmentary surgical procedure, the stapler instrument broke before use.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive white reload accessory to perform failure analysis.The accessory was analyzed and found to have a broken switch at the proximal end.The broken switch was not returned with the reload.Additional findings not reported by site: the reload was found to have a total of six staples missing from the reload pockets at the proximal end.One of the staples was returned however, the rest were not.The probable root cause of broken switch on reload accessory is attributed to a component failure.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) re-evaluated the white reload accessory for advance failure analysis.The instrument was analyzed and found to have a dislodged switch from the reload tail.The broken switch component could not be confirmed.It was additionally observed that the reload was returned with missing staples at the proximal end.No damage to the cartridge material was observed and the reload was not fired.Based on additional information, it has been determined that the probable root cause is not attributed to component failure as previously listed in section h10.Annex c and d were updated to reflect advanced failure analysis findings.

• 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: 22162612
• Report Number: 2955842-2025-24263
• Device Sequence Number: 8683290
• Product Code: GDW
• UDI-Device Identifier: 10886874121921
• UDI-Public: (01)10886874121921(10)U80240403
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K211997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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: U80240403 1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/07/2025
• Supplement Report FDA Received Date: 06/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• 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 Age: 73 YR
• Patient Sex: Male
• Patient Weight: 85 KG