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	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) will not receive the curved-tip sureform 45 stapler instrument and sureform 45 black reload for evaluation as they were discarded by the customer.A review of the submitted images was performed by an isi failure analysis engineer (fae).The following additional information was provided: it was observed that a curved-tip sureform 45 stapler instrument with an exposed blade and loose staples that were not deployed into the tissue.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the blade of the curved-tip sureform 45 stapler instrument was exposed when the customer physically opened the instrument's tips.An intuitive surgical, inc.(isi) technical support engineer (tse) advised the customer to replace the instrument.The procedure was completing as planned with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use, and no damage was found.The instrument involved a partial fire with the "tissue too thick to continue" error message, and the fire sequence was interrupted.The surgeon fired over an existing staple line.The surgeon did not use buttress material and did not experience any clamping issues prior to firing the sureform 45 black reload.The stapling issue did not result in malformed/unformed staples, staples missing, or holes/gaps observed within the staple line.The customer used another curved-tip sureform 45 stapler instrument to cut the tissue.The affected curved-tip sureform 45 stapler instrument was discarded as it was used on an infectious patient.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD BLACK
• 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: 20263829
• Report Number: 2955842-2024-19614
• Device Sequence Number: 8215366
• Product Code: GDW
• UDI-Device Identifier: 10886874117115
• UDI-Public: (01)10886874117115(10)K10230313
• 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
• Report Date (Section B): 08/26/2024

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: 48345T-01
• Device Catalogue Number: 48345T
• Device Lot Number: K10230313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2023
• 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