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	05/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting the stapler misfired twice and staples malformed, an investigation is pending to determine the cause of this reported event.An rma was issued to the customer requesting to have the intuitive surgical, inc.(isi) device returned.Additional information is being gathered to determine the contribution of the device to the customer reported issue.The product has not been returned for evaluation.Therefore, the root cause of the customer reported failure mode could not be determined.A follow-up mdr will be submitted when failure analysis has completed their investigation.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the curved-tip stapler 30 misfired twice.A backup instrument was obtained to complete the procedure.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer confirmed that the stapler incident involved a partial fire (firing sequence interrupted).There was no tissue push.There was an error message that stated, ¿remove stapler warning: blade may be exposed.¿ there were no obstructions.The surgeon did not fire over an existing staple line.There was no bleeding.The reload is available for return.However, there were malformed staples that looked like c in the attached malformed staple reference picture and an exposed blade.The customer stated there were staples missing from the staple line (due to the stapler only partially firing).There were no gaps in the line that was stapled.The reload was not stuck on the tissue.The surgeon used a 45 stapler load instead of a 30 to resolve the issue.The customer was using a green reload when the stapler misfired.The surgeon stapled five white loads and then two green loads, but both green reload misfired.
Additional Manufacturer Narrative
Failure analysis investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The green stapler 30 reload was analyzed and the complaint regarding a misfire was confirmed by failure analysis.The reload was found to have the knife exposed within the knife track.The reload was found to be partially fired.The reload was found to have a firing failure based on log review.Further investigation found additional observations.The reload was disassembled in-house for inspection.The reload was found to have a damaged blade.The blade exhibited mechanical indentations.No damage to the cartridge or the lead screw was observed.The curved-tip stapler 30 instrument was also returned for failure analysis and the investigation was completed.The instrument was tested on the in-house system.The instrument passed initialization on all three attempts.The instrument moved intuitively with full range of motion in all directions.The jaw opened and closed properly.The instrument clamped, fired, and unclamped successfully.The instrument was fired using a grey 30 reload.Visual inspection of the instrument found no external physical damage.The housing was removed from the back end, and no damage was observed.A site history review was performed and found a related complaint under patient identifier #699775, in which another green stapler 30 reload that was used during the same procedure was documented and reported.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• 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: 17083993
• Report Number: 2955842-2023-16019
• Device Sequence Number: 16852432
• Product Code: GDW
• UDI-Device Identifier: 10886874112844
• UDI-Public: (01)10886874112844(10)M10221113
• 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): 05/15/2023

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: M10221113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2022
• 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 Sex: Unknown