MAUDE Adverse Event Report: STANDARD BARIATRICS, INC. TITAN SGS GASTRIC STAPLER; STAPLE, IMPLANTABLE

Model Number SGS23R

Device Problems Failure to Advance (2524); Failure to Fire (2610)

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

Event Date 04/11/2023

Event Type  malfunction  

Event Description

During laparoscopic sleeve gastrectomy, the stapler stopped mid firing and would not proceed.After troubleshooting efforts were unsuccessful, the emergency mechanical abort function was used to remove the stapler from the tissue.The procedure was completed using an ethicon stapler and the case was completed without issue.

• Brand Name: TITAN SGS GASTRIC STAPLER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): STANDARD BARIATRICS, INC.
• MDR Report Key: 16743525
• MDR Text Key: 313412800
• Report Number: MW5116635
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SGS23R
• Device Lot Number: 085-22
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Male