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

Model Number	48630G-04
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, curved-tip stapler stopped mid staple and received an exposed blade message.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made multiple follow up attempts to obtain additional information.However, no further details have been received as of the date of this report.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.The reported event was addressed with phone support.The site was able to remove the suspected stapler and install a 45mm stapler to continue the procedure.Technical support engineer (tse) recommended to have the site return the suspect stapler instrument back for investigation.No site visit was conducted.The system was working properly, and no additional action was required as the issue was resolved.Advanced technical review (results): system log investigation: a review of the logs for the curved tip stapler 30 associated with this event has been performed by an intuitive surgical, inc.(isi) advanced failure analysis (afa) engineer.The following additional information was provided: the logs showed that this instrument was fired 2 times (1 white reload, 1 green reload, unsure of the order).The logs show one instance of error code 22030, indicating that one of the firings with this instrument during the procedure failed.Parameters indicate the failure was a general firing failure.There were no additional stapler related errors in the logs.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Image review: review of the provided images is consistent with the reported complaint.Root cause of the failure mode cannot be confirmed without the returned device.Images show that there are malformed staples sticking out of the reload.

• 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: 17803745
• Report Number: 2955842-2023-18676
• Device Sequence Number: 17928839
• Product Code: NAY
• UDI-Device Identifier: 10886874112844
• UDI-Public: (01)10886874112844(10)M10220717
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 08/31/2023

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: M10220717
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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