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

Model Number	48360W-08
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive has received the sureform stapler 60 and the white reload associated with this complaint and completed investigations.The reload was analyzed and damage was found to the reload.The returned reload was used and fired.Visual inspection displayed signs of physical damage to the cartridge and knife with lodged staples in between the track.There were 4-5 lodged staples in between the knife track.The blade was not exposed, and the staples were lodged in between the cartridge.The pushers and shutter were fully deployed.The staples were removed from the reload and cartridge damage was observed.The cover was removed to allow access to the knife and blade damage was observed.The reload blade was found to have mechanical indentations.The stapler instrument was analyzed and found to have 1 unclamp failure based on the log review that was not replicated in-house.The logs displayed 1 unclamp failure with error code 22030 an p1 value of 2, which confirms an unclamping failure.The stapler was installed onto an in-house system and fired on a test foam using in-house blue and white reloads.The instrument fired and unclamped successfully, and the resultant staple-line was visually inspected.The cutline appeared smooth and consistent, with no jagged edges or tearing observed.All staples were deployed and correctly formed into the proper b-shape.A review of the advanced technical logs for the sureform 60 stapler associated with this event has been performed by an intuitive surgical, inc.(isi) failure analysis engineer (fae).The following additional information was provided: logs show pn 480460-09, ln k10230829-0390, was installed on the system 2x and fired 2 reloads (1 blue, followed by 1 white).On each install, the first clamp was successful, and the firings were each completed with no pauses for compression.During the unclamping after the 2nd fire, the system detected a drivetrain failure.The unclamp failed at ~99.99%, per the dsp logs.Master supervisory controller (msc) logs show error codes 22030, and 282 at the same timestamp, representing the unclamping drivetrain failure, and subsequent force expiration of the instrument.The instrument was then removed and not used again in the procedure.As the instrument completed the unclamp to ~99%, there was likely no real need to use the stapler release kit (srk).Logs did not show use of the e-stop or srk.The failure occurred on the universal surgical manipulator (usm) 3, and fse notes refer to an error with usm 3.
Event or Problem Description
It was reported that during a da vinci-assisted sadi-s surgical procedure, after stapling with a sureform stapler 60 instrument, an error message popped up on the screen "possible failure detected while unclamping.Use grips to verify jaws are open.Do not reuse." the procedure was completed with no reported injury.

• 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: 19924866
• Report Number: 2955842-2024-17706
• Device Sequence Number: 20926555
• Product Code: GDW
• UDI-Device Identifier: 10886874113827
• UDI-Public: (01)10886874113827(10)N/A
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2024

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: 48360W-08
• Device Catalogue Number: 48360W
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2020
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White