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

Model Number	48345B-01
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary segmentectomy procedure, while stapling across the bronchus with a sureform 45 curved-tip stapler instrument loaded with a green sureform 45 curved-tip stapler reload, there was a partial fire, and the end of the staple line was not sealed.The staples from the end of the reload did not deploy.There was an unspecified amount of bleeding due to the gap in the staple line.The surgeon switched to a blue sureform 45 curved-tip stapler reload, and the same issue occurred.The surgeon switched to a laparoscopic stapler and continued the staple line, with no further issues.The stapler had fired an unspecified number of loads successfully, prior to this issue.The surgeon used an intraoperative bronchoscope to check the staple line.Both the green and blue reloads had exposed blades.Per the reporter, the surgeon downsized to a blue reload after using the green reload, due to the thickness of the target tissue at the end of the intended staple line.The target tissue was reportedly in a normal state, and the patient was reportedly in a normal condition following the procedure.Information regarding patient demographics, relevant testing, and medical history was requested, however the reporter was not able to provide that information.
Additional Manufacturer Narrative
Based on the customer's claim against the product, an investigation is in progress to determine the cause of this reported event.If additional information is obtained, a follow-up mdr will be submitted.Per a review of the site's system logs for the reported procedure date, no related system errors occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.A review of the advanced instrument log for the instrument associated with this event was performed by an intuitive surgical, inc.(isi) failure analysis engineer (fae).Per the fae, the logs show the instrument was installed on the system 3 times, and it fired 3 reloads (1 white, 1 green, 1 blue, in that order).On install 1, the first clamp was successful, and the firing was completed, with no pauses for compression.On install 2, the first clamp was successful, but it was followed by a firing failure.The firing stopped at ~89% completion, after a duration of 57 seconds.The maximum firing torque was recorded at 699 n.On install 3, the first clamp was successful, but it was followed by a firing failure.This firing stopped at ~78% completion, after a duration of 26 seconds.The maximum firing torque was recorded at 694 n.The instrument was then removed and was not used again in the procedure.There were no stapler related errors in the logs.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the blue sureform 45 curved-tip stapler reload associated with this complaint, and a failure analysis (fa) investigation was completed.Fa replicated and confirmed the customer reported complaint of a partial fire, with an exposed blade as the primary failure finding.The reload was found to have the knife exposed within the knife track.It was also found to have a firing failure, based on a log review during the in-house inspection.Commonly, the probable root cause of exposed components is typically attributed to misuse, such as firing across a staple line or other obstructions.Additionally, the reload was found to have mechanical indentation damage to the blade and cartridge damage, with a missing piece approximately 0.078" x 0.03" in size, that was not returned with the reload.This damage is commonly attributed to mishandling/misuse.Isi also received the sureform 45 curved-tip stapler instrument associated with this complaint, and a failure analysis (fa) investigation was completed.Fa confirmed, but did not replicate, the customer reported complaint of a partial fire, with a firing failure as the primary finding.The instrument was found to have firing failures, based on a review of the device logs, with an indeterminable probable root cause.The instrument was placed and driven on an in-house system, where it passed initialization and moved intuitively, with full range of motion in all directions.The jaws opened and closed properly, and the instrument clamped, fired, and unclamped, without any issues.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD BLUE
• 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: 17236361
• Report Number: 2955842-2023-16717
• Device Sequence Number: 5754891
• Product Code: GDW
• UDI-Device Identifier: 10886874117085
• UDI-Public: (01)10886874117085(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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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: 48345B-01
• Device Catalogue Number: 48345B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2022
• 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