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

Model Number	48360T-08
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The sureform 60 black reload was an incidental return with a sureform 60 stapler for a failure to grip issue.No allegation was made against the sureform 60 black reload.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) attempted follow-up to obtain additional information.However, no further details have been received as of the date of this report.
Additional Manufacturer Narrative
The sureform 60 black reload was returned to intuitive surgical, inc.(isi) for evaluation with no reported issue.An investigation has been completed.The reload was found to have the knife exposed within the knife track.The reload was found to have a firing failure based on log review and during in-house inspection.The partial fire log review revealed that during a sleeve gastrectomy, the partial fire completion was 48.39% on the second fire by the instrument and second overall firing number.The instrument had clamped six times.The reload was found to have mechanical indentation damage to the blade.The reload was found to have damage to the cartridge.The damage is located where the exposed blade stopped.The cartridge damage resulted in missing fragments not returned with the reload.The root cause of these failures is attributed to user mishandling.A review of the remotefe procedure log showed the sureform 60 stapler (part# 480460-09 /lot# l91220309 0310) associated with the returned sureform 60 black reload was used on a sleeve gastrectomy procedure performed on system (b)(4) on (b)(6) 2022.No image or video clip for the reported event was submitted for review.Based on the information provided at this time, this complaint is being reported due to the following conclusion: failure analysis acknowledges that a fragment was missing from a portion of the device that enters the patient (distal end).Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.

• 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: 15656870
• Report Number: 2955842-2022-14837
• Device Sequence Number: 17609436
• Product Code: GDW
• UDI-Device Identifier: 10886874113858
• UDI-Public: (01)10886874113858(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/23/2022

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: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2018
• 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