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

Model Number	48630B-04
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, while using the endowrist 30 curved tip stapler instrument across the bronchus, a partial fire occurred when firing a blue 30 reload accessory, followed by a green 30 reload accessory.The bronchus was clean with no tissue or lymph nodes around the bronchus at the time of clamping and firing.The first fire, staples were deployed, and the tissue was cut; but the reload aborted firing halfway through, with the blade exposed upon removal.The second fire was placed over the previous attempted fire, staples were deployed, and the tissue was cut; but the reload aborted firing halfway through again.Surgeon was not confident that formed staples were seen pass the cut line.The surgeon then switched to the sureform 45 stapler instrument and fired a black 45 reload accessory and completed the fire.Surgeon stated there was no bleeding, and no tissue being pushed forward or dragged during the firing process.There were no post-operative complications, and the patient was discharged home.The procedure was completed robotically.
Additional Manufacturer Narrative
The endowrist 30 blue reload was found to have an exposed knife and had a firing failure based on log review and during in-house inspection.The reload was found to have mechanical indentation damage to the knife blade as well as cartridge damage.The endowrist 30 green reload was found to have an exposed knife and had a firing failure based on a log review.The reload was also found to have cartridge damage in the knife track and lodged staples in the pusher pockets.The endowrist 30 curved tip stapler instrument was driven on an in-house system and passed initialization.The instrument moved intuitively with full range of motion in all directions.The jaw opened and closed properly and the instrument clamped, fired and unclamped without any issues.The stapler logs show for the endowrist 30 curved tip stapler instrument used during this event, show it was installed on the system 7 times and fired 6 reloads (1 green, 1 white, 1 green, 1 white, 1 green, 1 blue, in that order).On install 6 (green reload), the successful clamp was followed by a firing failure.The firing stopped at about 50% completion.On install 7 (blue reload), the successful clamp was followed by a second firing failure.This firing stopped at about 51% completion.This stapler instrument was then removed and not used again in the procedure.Refer to medwatch report (mdr) with patient identifier #: (b)(6) for additional information regarding the endowrist 30 green reload firing event.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Advance failure analysis (afa) investigations found the reload blade to have mechanical indentations.Additionally, reload cartridge damage was observed, likely a result of washer rotation.Both the blade indentations and cartridge damage/washer rotation observed were determined to likely be caused by firing across a hard object(s).

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 30 RELOAD
• 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: 18107749
• Report Number: 2955842-2023-20006
• Device Sequence Number: 6166479
• Product Code: GDW
• UDI-Device Identifier: 10886874112837
• UDI-Public: (01)10886874112837(10)M10221215
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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: 48630B-04
• Device Catalogue Number: 48630B
• Device Lot Number: 0544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2022
• 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 Age: 77 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White