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

Model Number	48345T-01
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigationwas completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) received the black sureform reload 45 involved with this complaint and completed the device evaluation.The stapler reload was inspected and found that the reload knife exposed within the knife track.Review of the stapler logs confirmed a partial firing event involving the reload.This confirms the customer reported event.As part of investigation, further inspection confirmed additional related failures.First was an indentation to the blade edge of the reload and second was a lodged staple that was obstructing the reload shuttle track where the knife edge was travelling towards the distal end of the reload.The information gathered indicates that the device did contribute to the customer reported issue.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the blade of the sureform 45 curved-tip stapler instrument installed with a black reload was not able to cut the tissue.The customer used the third-party stapler to continue with the procedure.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information regarding the reported event: the stapling issue did not result to either malformed or unformed staples.Staples were completely fired and no staples were missing from the staple line.Morevoer, no holes/gaps were observed within the staple line.The reload was not stuck to the tissue.After observing the exposed blade, instrument was removed safely.

• 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: 17715350
• Report Number: 2955842-2023-18336
• Device Sequence Number: 16703344
• Product Code: GDW
• UDI-Device Identifier: 10886874117115
• UDI-Public: (01)10886874117115(10)L10220801
• 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): 08/16/2023

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: 48345T-01
• Device Catalogue Number: 48345T
• Device Lot Number: L10220801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2022
• 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