MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER SHEATH

Model Number 410370-03

Device Problem Break (1069)

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

Event Date 11/29/2021

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted pulmonary lobectomy, the endowrist stapler sheath accessory broke while in use with a curved-tip stapler 30 instrument.The stapler sheath would not go through the trocar.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the procedure was able to be completed with a back-up instrument.There were no known errors/messages at the time of the reported issue.The procedure was completed with no reported injury.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the stapler sheath associated with this complaint and completed investigations.Failure analysis investigations confirmed the customer reported complaint that the sheath from the stapler was broken.Failure analysis found the primary failure of sheath damage to be related to the customer reported complaint.The sheath accessory was found to exhibit damage.The black heat shrink portion of the sheath was returned with obvious signs of the grey tubing torn off.The missing grey tubing was not returned.The curved tip stapler that was used with the stapler sheath was also returned and analysis was performed.The stapler was found to have the yaw plate cracked.The root cause of this failure is typically attributed to mishandling/misuse, such as excessive force applied to the distal end of the instrument.The stapler was tested in-house and the instrument initialized, clamped, fired, and unclamped without any issues.A review of the logs showed no failures.A review of the site's system logs for the reported procedure date was performed.Investigation revealed that there were no related system errors that occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.A review of the site's complaint history found no other complaints for this product.This complaint is considered a reportable event due to the following conclusion: failure analysis acknowledged that a fragment was missing from a portion of the device that enters the patient.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: ENDOWRIST
• Type of Device: STAPLER SHEATH
• 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 14008541
• MDR Text Key: 298308963
• Report Number: 2955842-2022-10894
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410370-03
• Device Catalogue Number: 410370
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2022
• Date Manufacturer Received: 03/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES