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

Model Number	48345W-01
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the investigation of an existing complaint, failure analysis investigation identified a potential fragment such as a lodged staple from the stapler sureform 45 white reload.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received a da vinci product under related record patient identifier (b)(6) / rma (b)(4) to perform failure analysis.The long bipolar grasper instrument was found to have a stuck metallic staple at the grip cable.The staple pin was intertwined in the grip cable.This could result to difficulty in opening and closing of the jaws.There were no evidence of discoloration or corrosion/contamination on the cables to indicate a reprocessing induced issue.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter on and obtained the following additional information on (b)(6) 2024: the procedure being performed was a pulmonary lobectomy.The date of the procedure was (b)(6) 2024.There were no reports of fragments falling within the patient.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retention of foreign material.There was no issue about the stapler.There were no stapler errors observed during the procedure.The surgeon did not encounter any obstructions such as clips, staples, or other hard material between the instrument jaws.The surgeon did not fire over an existing staple line.There was no bleeding observed on the staple line.No blood transfusion was administered.There was no unplanned tissue removal.The surgeon did not attempt to cauterize over a tissue that was previously stapled.The instrument (stapler) did not collide with another instrument or tool during procedure.The lodged staple did not fell into the patient¿s anatomy.Additionally, it was stated that the staple found in the long bipolar grasper instrument was due to the use of the same gauze to clean both the sureform stapler and the long bipolar grasper instrument.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The long bipolar grasper instrument was further evaluated by failure analysis engineer (fae) on (b)(6) 2024.The additional finding of a lodged component was confirmed.The component was removed and confirmed to be a staple.The tool table for the last procedure was reviewed and it was confirmed that a stapler and reloads were used in the procedure.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD WHITE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 20288595
• Report Number: 2955842-2024-19837
• Device Sequence Number: 20635286
• Product Code: GDW
• UDI-Device Identifier: 10886874117122
• UDI-Public: (01)10886874117122(10)N/A
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2024

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: 48345W-01
• Device Catalogue Number: 48345W
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 09/26/2024; 10/02/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/01/2024; 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2021
• 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: Prefer Not To Disclose