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

Model Number	48345T-01
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is in progress to determine the cause of this reported event.An return material authorization (rma) was issued to evaluate the intuitive surgical, inc.(isi) device.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that the staple of the sureform 45 black reload was malformed.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the sureform 45 black reload to perform failure analysis (fa).Fa was not able to confirm and reproduce the customer reported complaint.Visual inspection was performed, and the reload appears to be unused and not fired.The knife does not appear to be exposed.When compared to an in-house unused reload, no obvious difference with the placement of the blades were observed.Further investigation found the reload to have cartridge damage.No material appears to be missing.Additional analysis was performed on the black reload instrument by an advanced failure analysis engineer.Further inspection of the returned reload confirmed two staples from the proximal most pusher on the left side were missing.The staples were not returned with the reload, and they were not found in the bag containing the reload rma.Physical review and visual inspection of the reload confirmed that the reload was not fired.The blade position closely matched that of an in-house unfired black reload.The shuttle was found flush with the cartridge body, and the shuttle ramps showed no interaction with the first set of pushers.Damage to the proximal end of the cartridge on either side can occur due to installation or removal of a reload into stapler jaws.It is likely this reload was installed in a stapler; however, evidence suggests it was never fired.There are several 'in-line process controls' related to reload staple presence and protrusion during assembly of reloads.Staple loading via bowl feeders have two camaras to check for staple presence and performs an accept/reject check by the equipment.This is followed by a manual 100 percent check via mantis that specifically checks for staple protrusion and other staple-related conditions, including missing staples.The same mpi also requires the technicians to turn the reload upside down and check there is proper prong position.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD BLACK
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 18966451
• Report Number: 2955842-2024-12505
• Device Sequence Number: 6035577
• Product Code: GDW
• UDI-Device Identifier: 10886874117115
• UDI-Public: (01)10886874117115(10)L80230524
• 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,Followup
• Report Date (Section B): 02/26/2024

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: 48345T-01
• Device Catalogue Number: 48345T
• Device Lot Number: L80230524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 03/24/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• 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