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

Model Number 480460-09

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2023

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The sureform 60 stapler instrument was analyzed and found to have the wrist cove was found with a visible tear.Material, approximately 0.30" x 0.12", was missing from the wrist cover and not returned by the customer.Additionally, the chassis appears to be warped due to thermal damage.The instrument appears to be autoclaved or exposed to extreme thermal temperatures.The complaint was confirmed by failure analysis.

Event Description

It was reported that during a da vinci-assisted radical cystectomy (with ileal conduit) surgical procedure, the sureform 60 stapler got stuck when trying to take it out from the universal surgical manipulator (usm).When finally removed, the wrist guard looked broken.The procedure was completed as planned with no reported injury using a backup instrument.

Manufacturer Narrative

Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer could not confirm if the missing material occurred outside of the surgical procedure.There was no report of fragments falling from the device while used within a patient.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retention of foreign material.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: SUREFORM
• Type of Device: STAPLER 60
• 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: 19102537
• MDR Text Key: 340806198
• Report Number: 2955842-2024-13442
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115647
• UDI-Public: (01)10886874115647(10)T10230518
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K173721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480460-09
• Device Catalogue Number: 480460
• Device Lot Number: T10230518 0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.