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

Model Number	48345B-01
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting stapling issues, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) received the two blue stapler reloads involved with this complaint and device evaluation were completed.The reported event was not confirmed through failure analysis investigation.Inspection of both returned reloads confirmed that the reloads were used and fired without any issue.No cartridge damage was confirmed for both reloads.Further inspection after disassembly confirmed no damage to the reload knife on both reloads.Additionally, the sureform 45 stapler instrument was returned along with the blue reloads and isi completed the device evaluation.Review of the logs confirmed no firing failure.The instrument was functionally tested and passed all testing specification.The instrument was fully functional and operated without issue during testing.The customer reported complaint regarding was not confirmed by failure analysis.Isi reviewed the site¿s complaint history, and confirmed related records.Both stapler reloads were returned due to an alleged stapling issue.The submission under patient identifier (b)(6) represents the investigation on the 1st blue reload, while the submission under patient identifier (b)(6) (this report) represents the investigation on the 2nd blue reload.A review of the submitted image was performed by an intuitive surgical, inc.(isi) regulatory post market surveillance (rpms) analyst.The following additional information was provided: the image is consistent with an unformed (not b-shaped) staple.Although the issue was not confirmed through failure analysis, the probable cause is attributed to issues related to instrument errors or complications using the instrument reported by the user with no underlying product issue may be related to customer-induced problems, including misuse of the product.This complaint is considered a reportable event due to the following conclusion: it was alleged that after firing the surform 45 stapler instrument, staples were malformed, and the tissue was pushed forward.Malformed staples may contribute to an incomplete staple line.If not recognized during the procedure, medical intervention, including additional surgical procedures, may be required in the event that the staples are not formed as expected.At this time, it is unknown what caused the event to occur.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the sureform 45 stapler instrument installed with blue reload was used and inspection after stapling identified unformed staples (not b-shaped).The customer stated that no system message i.E.Tissue too thick to fire was displayed, and the resection was completed with "nominal" fire.The issue occurred twice on two blue reloads.The first occurrence happened between the upper and the middle lobe, and the second occurrence happened between the upper and lower lobe.After observing the issue, another reload (white reload) was installed into the same instrument to continue with the surgical task.User confirmed that no issue was experienced with the white 45 reload when used on the vessel.The user completed the procedure with no further issue reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the stapler and reloads were inspected prior to use with no issue.The reported event occurred during stapling on the upper middle lobe and between the upper and lower lobe.The customer stated that the tissue was not calcified and was not exposed to any radiation or chemotherapy.There was no tissue bunching.The event did not involve the following issues: failure to fire, partial fire, opening/releasing stapler jaws, unexpected staple being deployed, exposed blade, missing staples from the staple line, holes/gaps within the staple line, reload being stuck to tissue.The surgeon did not encounter any obstruction, clamping or firing over an existing staple line issue.Buttress material was not used.The surgeon mentioned that the tissue was "pushed forward/dragged a little during the firing process." there was no bleeding observed on the staple line and no unplanned tissue removal due to the issue.No known impact or patient consequence was reported.

• 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: 16691759
• Report Number: 2955842-2023-11794
• Device Sequence Number: 12282076
• Product Code: GDW
• UDI-Device Identifier: 10886874117085
• UDI-Public: (01)10886874117085(10)T90220422
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification,Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2023

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: 48345B-01
• Device Catalogue Number: 48345B
• Device Lot Number: T90220422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2022
• 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: ISIFA2022-02-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Sex: Unknown