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

Model Number	48630G-02
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the part involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint "customer put stapler 30 curved instrument with stapler30 green reload and completed clamping but error 'blade maybe exposed) occurred while firing.Customer removed it from the arm and found stapling was not completed (only half of stapler completed) and blade has been exposed." failure analysis found the primary failure of exposed component to be related to the customer reported complaint.The reload was found to have the knife exposed within the knife track.The reload was found to have a firing failure based on log review and during in-house testing.The reload was disassembled in-house for inspection and found no blade damage.Root cause is attributed to a component failure.An additional observation not reported by the site was that upon visual inspection, the reload appeared to have pusher damage on the midsection of the reload.Root cause is attributed to a component failure.Pusher damage was observed on the top and underside of the reload.Cartridge damage was observed at the same location as pusher damage.Damage was also noted on the underside of the cartridge.No material was missing.Root cause is typically attributed to user.Reload partial fire log review details: procedure was pulmonary lobectomy, partial fires (pf) completion percentage was 50.6%, firing number of pf by instrument in procedure was 5th firing, overall firing number of pf in procedure was 5th, and clamp history of instrument in procedure with pr was 5 complete clamps out of total attempts.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the customer used the stapler 30 curved instrument with the stapler 30 green reload and completed clamping but error "blade may be exposed occurred while firing.The customer removed the instrument from the arm and found only half of stapling was completed, and the blade was exposed.The customer used the thoracoscopy stapler to continue with the procedure.There was no report of fragment(s) falling inside the patient.The procedure was completed with no report of patient harm, adverse outcome, or injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use with no damage identified.When the stapler was in use for about 20 minutes, a blade may be exposed message appeared during the second fire after clamping.The surgeon did not experience any clamping issues prior to firing the stapler reload nor encounter any obstructions such as clips, staples, or other hard material between the instruments jaws.There were no malformed staples.The bronchus tissue was not calcified or exposed to any radiation or chemotherapy prior to the procedure.No tissue tension or bunching were observed.The surgeon did not use the buttress material.There was no report of patient injury.The stapler will be returned to isi for evaluation.No photographic images of the device(s) or a video recording of the procedure was available for isi review.

• 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: 17067435
• Report Number: 2955842-2023-15780
• Device Sequence Number: 15147614
• Product Code: GDW
• UDI-Device Identifier: 10886874112844
• UDI-Public: (01)10886874112844(10)M10180703
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2021

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-02
• Device Catalogue Number: 48630G
• Device Lot Number: M10180703 231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2018
• 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