MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; SUREFORM 45 RELOAD BLACK

Model Number	48345T-01
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The sureform 45 reload accessory was analyzed and found to have a knife exposed within the knife track, and a firing failure was observed during in-house observations and log review.The reload was partially disassembled for a visual inspection.Additional observations not reported by the site revealed that the reload was partially fired and disassembled in-house.The cartridge appeared to be damaged within the knife track and near the pusher damage locations.Upon a visual inspection, the staples that were still present on the deployed pushers were found to be malformed.The staples were not found to be fully formed.The reload was found to have pusher damage on the pushers with the malformed staples.The complaint was confirmed by failure analysis.A review of the logs for the sureform 45 stapler associated with this event has been performed by an intuitive surgical, inc.(isi) afa.The following additional information was provided: logs show pn 480545-04, ln l10230330-0566, was installed on the system 12x and fired 10 reloads (6 blue, 2 white, 1 green, 1 black, in that order).On installs 1-5, the first clamp was successful, and the firings were each completed with no pauses for compression.On installs 6 and 7, no clamping or firing was performed.On install 8, the user was prompted to manually select the reload color, due to not firing on the previous install.The blue reload was selected.On installs 8-10, the first clamp was successful, and the firings were each completed with no pauses for compression.On install 11, the first clamp attempt was incomplete, stopping at ~62% completion.The next 2 clamp attempts were successful but were followed by a firing failure.The firing stopped at ~48% completion.After a duration of ~24 seconds.Peak torque was measured at 694 n.On install 12, the first clamp was successful but was followed by a firing failure.The firing stopped at ~51% completion, after a duration of ~34 seconds.The user then initiated force fire, however, that also resulted in a failure at ~63% completion.This failure resulted in error code 22030 in the logs.The instrument was then removed and not used in the procedure again.There were no additional stapler-related errors in the logs.Blank mdr fields: the missing patient information in sections b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the surgeon was unable to complete the staple fire.The surgeon tapped the blue pedal to unclamp then removed the stapler.There was a ¿warning blade may be exposed¿ message.The procedure was completed with no reported injury.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The reload was analyzed further.This reload was returned partially fired, with the blade exposed from the surface of the reload.The blade stopped traveling at approximately 60% of the way down the reload, which aligns with the approximately 63% completion for the force fire event shown in the procedure logs.The reload was returned with the stapler used in the procedure.The stapler was investigated and found to have no abnormalities or issues, and the failure was not replicated through in-house testing.Inspection of the reload revealed no shuttle damage and only one minor indentation to the blade cutting edge.Severe inner cartridge damage was observed at the proximal end knife track on either side of the reload.The surface of the cartridge had multiple indentations and scratches, correlating to the damage to the pushers.Additionally, the surface near the blade stopping point and where the malformed lodged staples were located appears to be crushed.Pusher damage was observed on a few pushers on the left side of the reload only.The pushers were found to have deformed edges.Additionally, malformed staples were observed to still be remaining in their pusher pockets.The crushed/damaged cartridge surface, pusher damage, and malformed staple may all be related to the high firing forces during the firing sequence.Malformed staples can occur as the pushers become damaged and do not properly hit the anvil pockets.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD BLACK
• 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: 18133603
• Report Number: 2955842-2023-20195
• Device Sequence Number: 12700869
• Product Code: GDW
• UDI-Device Identifier: 10886874117115
• UDI-Public: (01)10886874117115(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K183224
• 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): 10/23/2023

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: 48345T-01
• Device Catalogue Number: 48345T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 12/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2020
• 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: 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: 59 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White