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

Model Number	48360T-08
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.The reload was found to have the knife exposed within the knife track.The reload was partially fired and was found to have a firing failure based on log review.The reload was also disassembled in-house for inspection.The reload was found to have cartridge damage along the knife track.The reload was found to have a damaged blade.The blade exhibited mechanical indentations.No material appeared to be missing.The reload was found to have damaged pushers.
Event or Problem Description
It was reported that during a da-vinci assisted low anterior resection surgical procedure, the customer had issues with the exposed blade error message when using the stapler 60 instrument.The staple line was robotically finished with a needle driver instrument.The procedure was completed with no patient harm.The stapler was inspected prior to use and nothing unusual was noted.The surgeon was attempting to staple soft intestinal tissue.The stapler experienced a blade exposed error on the system partway through the stapling.The stapler instrument worked partially.The surgeon used black and green reloads with the same issue.The stapler was only briefly in use as the issue occured with the first staple fire.The surgeon did not encounter any obstructions and no buttress material was used.There were no malformed staples and no clamping issues prior to firing.Intestinal tissue was target tissue.No tissue was stuck on the reload or the stapler.The surgeon was able to remove the partial staple line and sew it up robotically using a needle driver instrument.There was no excessive bleeding and no leaking.The tissue was not calcified nor exposed to radiation.There was no tissue tension.Surgeon could not confirm the exact thickness of tissue grasped and thought a reasonable amount of tissue was grasped for stapling.Green and black reloads as well as the stapler instrument are being returned.No photographic images or video recordings are available.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 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: 17067437
• Report Number: 2955842-2023-15782
• Device Sequence Number: 6673082
• Product Code: GDW
• UDI-Device Identifier: 10886874113858
• UDI-Public: (01)10886874113858(10)L90191028
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 10/28/2021

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: L90191028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2019
• 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: Female