MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER 30 RELOAD GREEN

Model Number	48630G-04
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the stapler 30 failed to fire.The customer switched to a stapler 45 to complete the stapling.System logs confirmed failure during firing of stapler 30mm.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter on and obtained the following additional information: it was confirmed that the instrument was inspected with no noted damage.It was a green reload when the issue occurred.The stapler did work previously.It was unknown on which fire the issue occurred.When the issue occurred, the stapler clamped down, started to fire and presented an error message ¿load did not fire completely¿.The blade pushed out roughly 5 mm and deployed some of the staples on the proximal end.There were malformed staples that looked like a box shape (option u on attached malformed staples chart).The surgeon removed all partially fired staples.No tissue was removed.A new stapler was opened to resolve the issue.There were no obstructions such as clips, staples, or other hard material between the instrument jaws.There was no additional bleeding along the staple line.There were no noted holes or gaps.The procedure was completed robotically.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the stapler reload as an rma.There was no alleged malfunction reported against this accessory.Although there is no claim against the product, an investigation was completed to determine the cause of this reported event.The stapler reload was analyzed and found to have pusher damage.One of the pushers was bent.No missing material.The reload was found to have lodged staples, which were malformed and located in the pusher pocket.Additionally, the reload was found to have the knife exposed within the knife track.Firing failure was noted based on log review and during in-house inspection.Mechanical indentation damage to the blade edge and cartridge damage along the knife track were also found during the failure analysis investigation.No missing material.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 30 RELOAD GREEN
• 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: 17122181
• Report Number: 2955842-2023-16281
• Device Sequence Number: 20445088
• Product Code: GDW
• UDI-Device Identifier: 10886874112844
• UDI-Public: (01)10886874112844(10)M10221108
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152421
• 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): 05/22/2023

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: 48630G-04
• Device Catalogue Number: 48630G
• Device Lot Number: M10221108 0340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2022
• 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 Age: 66 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White