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

Model Number	48360W-10
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the white sure form 60 reload for failure analysis evaluation.The event investigation is in progress.
Event or Problem Description
It was reported that during a da vinci-assisted subtotal gastrectomy procedure, the staples from a white sureform 60 reload did not fully deploy and the stapling sequence was not fully completed.The procedure was completed robotically.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the event occurred during the 2nd stapler fire on stomach tissue as part of a sleeve gastrectomy.The stapler instrument had initially worked for the first firing.The stomach tissue was not calcified or exposed to any radiation or chemotherapy prior to the procedure, and there was no tissue tension or tissue bunching.The stapler instrument clamped down normally and was ready to fire.During the firing, the stapler instrument partially fired and had stopped with a tissue too thick to continue message.The stapling issue resulted with a few loose and unformed staples which were removed beyond the stop point.The staple line was otherwise intact.The stapler reload had an exposed blade.There were no staples missing from the staple line.There were also no holes/gaps observed within the staple line.The surgeon encountered a number of stapling error messages during the event.The surgeon did not encounter any obstructions such as clips, staples, or other hard material between the instrument jaws.Buttress material was not used.The surgeon did not experience any clamping issues prior to firing the stapler reload.No bleeding was observed on the staple line due to the stapler issue.There was no unplanned tissue removal due to the stapler firing failure.The stapling issue did not result in holes/gaps (unapproximated tissue) in the staple line.The surgeon was able to continue the procedure using other white sureform 60 reloads.There are video files available for isi to review.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Additional information: as of the date of this report, intuitive surgical, inc.(isi) has not received the white sureform 60 reload involved with the reported event.An instrument log review could not be conducted due to insufficient information provided.The batch sequence # of the associated white sureform 60 reload was not provided.A device history record (dhr) review for the device(s) involved with the reported event has been completed.No non-conformances were identified to be related to this complaint.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 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: 21405224
• Report Number: 2955842-2025-01620
• Device Sequence Number: 15507742
• Product Code: GDW
• UDI-Device Identifier: 10886874113827
• UDI-Public: (01)10886874113827(10)K11240801
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48360W-10
• Device Catalogue Number: 48360W
• Device Lot Number: K11240801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown