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

Model Number	48630W-04
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The stapler 30 white reload was analyzed and found to have the knife exposed within the knife track.Additionally, the blade had mechanical indentation damage and a piece approximately 0.021" x 0.02" was missing.The reload was also found to have a lodged staple in the staple pocket.The staple was partially formed, and pusher was deployed.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.The stapler 30 curved-tip instrument was found to have a firing failure based on log review.The instrument was placed and driven on an in-house system.The instrument passed initialization.The instrument moved intuitively with full range of motion in all directions.The jaw opened and closed properly.The instrument clamped, fired and unclamped without any issues.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the curved-tip stapler 30 instrument stopped while firing across a vessel.Use of the instrument was discontinued, and it was replaced to the backup.The procedure was completed with no reported injury.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The stapler 30 white reload was transferred and evaluated by the by the failure analysis engineering (fae) team.The initial fa findings were confirmed.The blade was microscopically inspected and was observed to have minor indentations along the cutting edge, as well as a larger nick of the material at the blade tip.Fa confirmed that material appeared to be missing from the blade.The reload body and knife track were inspected for damage and blade fragments.No damage to the cartridge material was noted.Corrosion was observed on the reload shuttle, likely due to storage/transit time.Corrosion was not likely present during the procedure.A metal fragment was found at the distal tip, where the blade retracts back into the reload body at the end of the firing sequence.Metal fragment appears to be sheared from a metal reload component.Leadscrew, shuttle, and wash were inspected for damage, and did not appear to be missing material.As fragment was retained within the cartridge body by the reload cover, and was located through visual inspection, there was no potential for fragments from this failure.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 30 RELOAD WHITE
• 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: 18441726
• Report Number: 2955842-2023-21920
• Device Sequence Number: 6751867
• Product Code: GDW
• UDI-Device Identifier: 10886874112868
• UDI-Public: (01)10886874112868(10)K10230713
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 12/13/2023

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: 48630W-04
• Device Catalogue Number: 48630W
• Device Lot Number: K10230713 0998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White