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

Model Number	48630W-04
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
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 a firing failure based on log review and during in-house inspection.A review of logs showed one firing failure.The reload was observed to have the blade slightly out of the blade garage, indicating that it was returned partially fired.Additional observation not reported by site: the reload was observed to have undeployed pushers.The shuttle was observed at the location of the first set of pushers.One of each set pusher still had an unformed staple present and was not deployed.The reload partial fire log reveals the procedure was a pulmonary lobectomy.The partial fire completion percentage was 10.69%.The firing number of partial fire by the instrument in the procedure was identified as the 1st fire.The overall firing number of partial fires in the procedure was identified as the 4th fire.The clamping history of the instrument in the procedure with partial fire identified one complete clamp out of one total.The curved-tip stapler 30 instrument was tested in-house, and the instrument initialized, clamped, fired, and unclamped without any issues.The instrument moved intuitively with a full range of motion in all directions and the grips opened and closed properly.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the curved tip 30 stapler instrument was making a grinding noise and did not fire.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Further investigation was performed on the reload by advanced failure analysis engineer.The initial failure analysis findings were confirmed.The reload was returned with two staples not deployed from the first row of pushers.The staples were unformed, and still in the 'u' shape.Review of procedure logs show an incomplete firing, stopping at ~10% completion.Completion percentage aligns with the forward progress of the shuttle down the reload.The reload leadscrew was manually rotated and the shuttle was able to move forward past the point of failure.Staples were deployed properly.The reload was then disassembled for further review.No damage was observed to the reload.The leadscrew was not damaged and appeared adequately lubricated.The shuttle was not damaged, and no friction was detected during manual manipulation.The reload blade was still contained within the proximal garage, indicating that the tissue had not likely been cut.The returned stapler that fired this reload was re-fired through in-house testing and no errors, abnormal noise, or undeployed pushers were observed.This reload was transferred to engineering for further review.No manufacturing errors, or root cause for the reported complaint was determined.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• 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: 18135449
• Report Number: 2955842-2023-20272
• Device Sequence Number: 20771625
• Product Code: GDW
• UDI-Device Identifier: 10886874112868
• UDI-Public: (01)10886874112868(10)M10230202
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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: 0152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• 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