MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; STAPLER 60

Model Number	480460-12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the sureform 60 stapler instrument to perform failure analysis.A review of an image provided by the customer was conducted.Based on the the review, it was confirmed that there was damage to a sureform 60 stapler instrument wrist cover.This component is a silicone elastomer used to protect the inner components of the wrist, and to protect from fluid ingress to the stapler.The wrist cover appears to be damaged and missing material in multiple small spots but only see one black fragment is noted on the white surface.
Event or Problem Description
It was reported that during a da vinci-assisted right hemicolectomy procedure, a black fragment was noticed inside the patient after using a sureform 60 stapler instrument.The customer stated there were holes "noted in the rubber at the rubber flexing".The fragment was retrieved by the surgeon, the abdomen was examined thoroughly, and an x-ray was performed to confirm all fragments were retrieved at the time of the event.The customer stated to their knowledge, there was no injury or complication due to this event.The sureform 60 stapler instrument is being sent back to intuitive surgical, inc.(isi) for evaluation; however, the fragment was thrown away.The procedure was completed robotically, with no additional surgical procedures required to remove the fragment.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive the sureform 60 stapler instrument to perform failure analysis.The sureform 60 stapler instrument was analyzed and found to have the snake wrist cover torn.The tears measured roughly 0.1640"- 0.1865".Visual inspection displayed no signs of missing fragments.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60
• 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: 24683994
• Report Number: 2955842-2026-17565
• Device Sequence Number: 18555027
• Product Code: NAY
• UDI-Device Identifier: 10886874115647
• UDI-Public: (01)10886874115647(10)K17251106
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173721
• 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,Followup
• Report Date (Section B): 05/15/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 480460-12
• Device Catalogue Number: 480460
• Device Lot Number: K17251106 0139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2025
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown