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

Model Number	48630G-04
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, when the green reload was used for dissecting the bronchi, there was no particular problem with clamping nor was the tissue forced into the jaw; however, when fired, the blade stopped and a partial fire event occurred.It was reported that after removing the "non-formed" staples, the surgeon used another green reload for separation.It was further reported that an external stapler instrument (gia black) was also used for the surgical task and a similar issue was also experienced.The reporter noted that the bronchi was not particularly thick nor was hard tissue clamped in between the jaws when the partial fire event occurred.The doctor reportedly felt that the frequency of green reload problems has increased recently.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument/accessory was inspected prior to use and there was no damage or anything out of the ordinary.The fourth stapler fire was involved with the reported event.An error message of "blade may be exposed" was generated when the stapling issue occurred.The surgeon did not encounter any obstructions such as clips, staples, or other hard material between the instrument jaws and buttress material was not used.The target tissue was not calcified and was not exposed to any radiation or chemotherapy prior to the procedure.There was no tissue tension and bunching.No injury occurred to the patient.There is a video recording of the procedure available for isi review.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the stapler reload involved with this complaint and completed the device evaluation.The reported event was confirmed through failure analysis investigation.Inspection found the knife exposed within the knife track.Testing reproduced the firing failure indicating the reload was partially fired.No blade damage was observed.The cartridge was found damaged.The known cause of this issue is attributed to mishandling / misuse.

• 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: 16925189
• Report Number: 2955842-2023-13114
• Device Sequence Number: 6841590
• Product Code: GDW
• UDI-Device Identifier: 10886874112844
• UDI-Public: (01)10886874112844(10)M90200210
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48630G-04
• Device Catalogue Number: 48630G
• Device Lot Number: M90200210 294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2020
• 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: 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