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

Model Number	48360T-08
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Failure analysis investigations confirmed the customer-reported complaint.The sureform stapler 60 black reload was found to have the knife exposed within the knife track.The reload was found to have a firing failure based on log review and was observed during in-house observations.Additional observations not reported by site: the reload was found to have a lodged malformed staple stuck in the knife track at the distal tip of the reload.The staple was removed successfully.The reload was observed to be partially fired.The reload was disassembled in-house and the cartridge appeared to be damaged within the knife track.The damages within the knife track were observed near the location of the exposed component.The reload was found to have pusher damage near the location of the exposed component.The reload was found to have blade damage when the reload was disassembled in-house.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary wedge resection surgical procedure, the sureform stapler 60 black reload stopped firing unexpectedly.The target tissue was the lung.The reload and stapler were removed from the sterile field, and it shows that only half of the staple load was fired correctly.The customer opened new staple and new stapler to complete the job.Intuitive surgical, inc.(isi) followed up with the initial reporter on and obtained the following additional information: the procedure was completed robotically with a back up instrument.There was no harm or injury to the patient.No fragments fell into the patient.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 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: 18142700
• Report Number: 2955842-2023-20287
• Device Sequence Number: 6420963
• Product Code: GDW
• UDI-Device Identifier: 10886874113858
• UDI-Public: (01)10886874113858(10)K13221206
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 10/25/2023

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: 48360T-08
• Device Catalogue Number: 48360T
• Device Lot Number: K13221206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2022
• 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