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

Model Number	48345B-03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the sureform 45 blue reload was found to be damaged.After the procedure, fragments consistent with the reported damage were discovered in a saline bottle used for post-procedure cleaning by the central sterile processing department.A backup da vinci reload was used to complete the procedure.The procedure was completed as planned with no reported patient injury.Intuitive surgical, inc.(isi) contacted the customer and obtained the following information: there was no damage/no patient impact was reported.(the fragment was discovered during the procedure and cross-checked against the cartridge.) the stapler was used as-is, and the operation was completed.As a precaution, all used reload units have been sent to you.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the sureform 45 blue reload to perform failure analysis (fa).Fa was able to confirm and reproduce the customer reported complaint.The reload was found to have exterior damage at one of the proximal flanges of the cartridge.There may be missing material, but the size of the missing pieces cannot be confirmed.The probable root cause is contributed to use conditions (i.E.Due to reload removal).Additional observation not reported by site: the reload was found to have undeployed pusher.One of the pushers was undeployed with "b" shaped staple stuck in the staple pocket near the distal end of the reload.The pusher was manually activated and without much effort it moved to its final position, pushing the staple out of its pocket.The staple was lost during fa.

• Brand Name: SureForm
• Common Device Name: SUREFORM 45 RELOAD BLUE
• 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 ; +1(408)523-2100
• MDR Report Key: 50207162
• Report Number: 2955842-2026-35163
• Device Sequence Number: 20214075
• Product Code: GDW
• UDI-Device Identifier: 10886874117085
• UDI-Public: (01)10886874117085(10)K10260205
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183224
• 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
• Report Date (Section B): 08/11/2026

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: 48345B-03
• Device Catalogue Number: 48345B
• Device Lot Number: K10260205 NA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2026
• 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