MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; SUREFORM 45 RELOAD GRAY

Model Number	48345M-03
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis, and the complaint was confirmed.The sureform 45 gray reload accessory was analyzed and found to have the blade rotated within the knife track.The blade was not exposed above the surface.There was also cartridge damage noted at the site of the rotated blade.No information on the sureform stapler that was used was provided, so no logs are available for review at this time.Additionally, the reload was found to have cartridge damage.The cartridge was damaged between the knife track at the site of the blade rotation.The reload parts were separated for further investigation.The reload cartridge was damaged and there may be missing pieces; however, the size of the missing pieces cannot be confirmed, indicating that a fragment may have detached from the reload.The reload blade was found to have mechanical indentations.The blade was damaged at the tip, as a result of the rotated blade.The probable root cause of the reported complaint is attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments or hard surfaces.Furthermore, the probable root cause of reload damage is attributed to high firing torques, which can result from firing on challenging tissue (e.G., tissue condition) or hard objects (e.G., staples).
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the sureform 45 gray reload accessory stapling stopped.A backup was used to complete the procedure with no patient harm.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD GRAY
• 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: 25030045
• Report Number: 2955842-2026-23201
• Device Sequence Number: 21356519
• Product Code: GDW
• UDI-Device Identifier: 10886874117108
• UDI-Public: (01)10886874117108(17)271130(10)K10241114
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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: 48345M-03
• Device Catalogue Number: 48345M
• Device Lot Number: K10241114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/14/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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