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

Model Number 480460-08

Device Problem Use of Device Problem (1670)

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

Event Date 02/24/2022

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the customer reported event can be attributed to use error.The instrument was discarded by the site and is not available for evaluation.If additional information is received, a follow-up mdr will be submitted.The da vinci x/xi instrument & accessory catalog states: training instruments are not approved for human use.Training instruments can be readily identified by the red instrument housing.Red instrument icons persist on the monitors when a training instrument is loaded onto the system.No image or video clip for the reported event was submitted for review.This complaint is reportable due to the following conclusion: during a da vinci-assisted sleeve gastrectomy surgical procedure, the staff had accidentally used a brand new sureform 60 stapler training instrument on a patient.The surgeon fired the training sureform 60 stapler instrument 3 times during the procedure.As soon as the staff realized the issue, the training instrument was removed.The patient was administered prophylactic antibiotics after the surgery was completed.There were no reported post-operative complications.

Event Description

It was reported that during a da vinci-assisted sleeve gastrectomy surgical procedure, the staff had accidentally used a brand new training sureform 60 stapler instrument.The surgeon fired the training stapler instrument 3 times using 2 green and 1 blue stapler reloads.Intuitive surgical, inc.(isi) followed up with the surgeon and obtained the following information: the user was not aware that the instrument was labeled as not for human use (nfhu).Once the issue was realized, the instrument was removed and discarded.The patient did not develop any post-operative symptoms of infections but was administered antibiotics (ancef) after the procedure as a prophylaxis.

• 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: 13876424
• MDR Text Key: 293147427
• Report Number: 2955842-2022-10739
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115647
• UDI-Public: (01)10886874115647(10)L90190708
• Combination Product (y/n): N
• PMA/PMN Number: K173721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 480460-08
• Device Catalogue Number: 480460
• Device Lot Number: L90190708 0158
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2019
• 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