MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; STAPLER 60 RELOAD BLACK

Model Number	48360T-08
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted gastric sleeve surgical procedure, the sureform stapler instrument installed with a black reload failed to fire completely leaving the blade exposed.At the time of the firing, the system prompted to pause to reassess the tissue thickness.A gore seamgaurd staple line reinforcement was placed over the black reload before the insertion of the stapler.The site was able to remove the reload without further incident and another black reload was used to complete the stapling of the stomach.There was no reported fragment that fell into the patient.The procedure was completed with no reported injury.Intuitive surgical, inc (isi) followed up with the site's initial reporter and obtained the following information regarding the reported event: the instrument was inspected prior to the issue, and nothing out of the ordinary was noted.The reload color involved with the reported event was the back reload.The black reload was picked due to the thickness of the tissue.The issue happened at the third staple fire.The task being performed at the time of the issue was while stapling the stomach.The tissue was not noted to be calcified, exposed to chemotherapy, or have tissue tension or bunching.The issue involved failure to fire and partial fire.The issue did not involve tissue being pushed forward/dragged during the firing process.Additionally, it did not involve the stapler jaws opening/releasing during the firing sequence.No staples were deployed unexpectedly.There were no malformed, missing holes or gaps in the staple line.The blade was noted to have an exposed blade.The reload was not stuck to the tissue.The customer encountered a " tissue too thick to continue" error message.No obstructions were encountered by the surgeon.The surgeon did not fire over any existing staple line.Buttress material was used.The surgeon experienced clamping issues prior to firing the stapler reload.No bleeding was observed on the staple line due to the stapler issue.The tissue had no holes/gaps in the staple line.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The sureform 60 black reload was analyzed and reported failure was confirmed.The reload was found to have lodged staples bunched up where the exposed knife is located.The knife was exposed towards the proximal end of the returned reload.Visual inspection confirmed a 3 lodged staples ahead of the blade stopping point, which can prevent the blade from progressing through full firing trajectory.Additionally, the reload was disassembled and the reload was found to have cartridge damage along the knife track.No material appears to be missing.The reload was found to have a damaged blade.The blade exhibited mechanical indentations.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 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: 19362054
• Report Number: 2955842-2024-14834
• Device Sequence Number: 3785415
• Product Code: GDW
• UDI-Device Identifier: 10886874113858
• UDI-Public: (01)10886874113858(10)L10220808
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2024

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: 48360T-08
• Device Catalogue Number: 48360T
• Device Lot Number: L10220808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• 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 Age: 34 YR
• Patient Sex: Female
• Patient Weight: 141 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White