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

Model Number	48630M-05
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the reload involved in the complaint for evaluation.However, the failure analysis has not been completed yet.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the stapler 30 instrument fired; however, no staples, or blade went across the tissue.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The stapler 30 reload accessory was analyzed and the complaint was not confirmed by failure analysis.Loose staples were cleared from the jaw of the stapler.The stapler along with the reload were installed on an in-house system where it clamped, fired, and unclamped successfully.No product issue was identified.The curved-tip stapler 30 instrument was found to have staples lodged at the base of the channel.The lodged staple caused the leadscrew to not turn.This was an expected or random component failure without any design or manufacturing issue.The instrument is being forwarded to engineering for additional analysis.A review of the logs found reload recognition failures.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) failure analysis initial findings were confirmed.The reload was returned unfired and was fired successfully with the returned stapler.No damage to the reload was observed.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use with nothing noted out of the ordinary.A gray reload was involved in the event and a gray reload is used all the time due to the thickness of the tissue.The issue occurred when firing over a pulmonary artery vessel.The fire mode fired, however, no staples/blade were deployed.No holes/gaps, no missing staples or errors were observed.No buttress material was used.A new stapler instrument was used to resolve the issue.Additionally, the isi failure analysis engineer (fae) partially confirmed the initial findings.The instrument was transferred with staples still lodged in the crotch of the stapler jaws.Staples remaining in the jaws after a firing may cause shorting of the reload pins and can lead to reload detection issues.Review of the procedure logs show one instance where a valid reload was not detected in the field.This was resolved by manually selecting the reload color on the surgeon side console (ssc) touchpad.The staple was removed in-house, and a blue reload was installed into the stapler jaws.The instrument engaged and initialized.The instrument moved intuitively in all directions.Clamping, firing, and unclamping were all completed without error.The instrument was fully functional.Based on the failure analysis results of the reload return with this stapler, the reported event is likely the result of a lodged staple at the reload leadscrew.The lodged staple likely prevented the mating of the reload leadscrew and the leadscrew socket of the stapler.This caused the instrument socket to rotate, indicating to the system that the firing was being completed.The torque during the firing was just high enough for the system not to flag as an error, and so low the no partial fire was triggered.The reported event of the stapler appearing to complete a firing, without deploying the knife or staples from the reload was confirmed but was not replicated.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 30 RELOAD GRAY
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 20412600
• Report Number: 2955842-2024-20328
• Device Sequence Number: 18173953
• Product Code: GDW
• UDI-Device Identifier: 10886874112851
• UDI-Public: (01)10886874112851(10)K11240327
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/18/2024

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: 48630M-05
• Device Catalogue Number: 48630M
• Device Lot Number: K11240327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 10/15/2024; 11/05/2024; 11/26/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/06/2024; 11/27/2024; 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2024
• 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: Prefer Not To Disclose