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

Model Number	48345W-03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, it was noted that after attaching and using the sureform 45 black and white reloads, the plastic parts on both sides of the attachment site fell off and into to the patient.The fragment(s) were retrieved during the same procedure.There was no instrument collision.
Additional Manufacturer Narrative
The white reload has not been returned.Medwatch report (2955842-2025-34953) was submitted for the sureform 45 black reload.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive sureform 45 white reloads to perform failure analysis.The white reload #1 was analyzed and found to have cartridge damage.The cartridge was damaged at the proximal end of the reload near the reload cover.Material was found to be missing.The reload was not returned with a stapler instrument.The white reload #2 was analyzed and found to have cartridge damage.The cartridge was damaged at the proximal end of the reload near the reload cover.Material was found to be missing.The reload was not returned with a stapler instrument.The white reload #3 was analyzed and found to have cartridge damage.The cartridge was damaged at the proximal end of the reload near the reload cover.Material was found to be missing.The reload was not returned with a stapler instrument.The white reload #4 was analyzed and found to have cartridge damage.The cartridge was damaged at the proximal end near the start of the reload cover.There was missing material confirmed.The reload was not returned with a stapler instrument.The white reload #5 was analyzed and found to have cartridge damage.The cartridge was damaged at the proximal end of the reload near the reload cover.Material was found to be missing.The reload was not returned with a stapler.The white reload #6 was analyzed and found to have cartridge damage.The cartridge was damaged at the proximal end of the reload near the reload cover.Material was found to be missing.The reload was not returned with a stapler instrument.The 4.6 black sureform 45 reload was analyzed and found to have a lodged staple wedged in between the reload during visual inspection.The staple was removed, and the reload was inspected.The reload was found to have cartridge damage.The cartridge was damaged between the knife track at the site of the lodged staple.The reload parts were separated for inspection, and damage to the blade was confirmed.There were missing pieces of the cartridge that were not returned.Additional observation(s) related to customer reported complaint: the reload blade was found to have mechanical indentations.The reload cover was removed, the reload was inspected.Damage was found on the blade.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.Additional h10: the following manufacturer report numbers were submitted for the sureform 45 white reloads that were found damaged with missing material.It is unclear which reload contributed to the fragment falling into the patient.#5 white reload 2955842-2025-39931.#6 white reload 2955842-2025-39932.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD WHITE
• 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: 22860071
• Report Number: 2955842-2025-34954
• Device Sequence Number: 15386791
• Product Code: GDW
• UDI-Device Identifier: 10886874117122
• UDI-Public: (01)10886874117122(17)280430(10)U10250404
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K183224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48345W-03
• Device Catalogue Number: 48345W
• Device Lot Number: U10250404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2025
• 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