MAUDE Adverse Event Report: STANDARD BARIATRICS, INC. TITAN SGS; STAPLE, IMPLANTABLE, PRODUCT CODE: GDW

Model Number	SGS23R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	12/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient developed a leak on (b)(6) 2022 following a sleeve gastrectomy procedure completed on (b)(6) 2022, which had used the titan sgs23r stapler.The location of the leak was not able to be confirmed although it was reported that an obstruction occured at the middle part of the stomach.Additionally, it was reported that the patient was thought to be non-compliant.Re-operation/surgical intervention was completed however no details were reported regarding specifically what occured during re-operation.It was reported that the patient was released after re-operation/surgical intervention.Standard bariatrics was notified of this event on (b)(6) 2023.

• Brand Name: TITAN SGS
• Common Device Name: STAPLE, IMPLANTABLE, PRODUCT CODE: GDW
• Manufacturer (Section D): STANDARD BARIATRICS, INC.; 4300 glendale milford road; cincinnati OH 45242
• Manufacturer Contact: tony yux ; 4300 glendale milford road; cincinnati, OH 45242 ; 5136207751
• MDR Report Key: 16882320
• Report Number: 3012481535-2023-00001
• Device Sequence Number: 7256657
• Product Code: GDW
• UDI-Device Identifier: 00851677007089
• UDI-Public: 00851677007089
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K210278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2023
• Device Model Number: SGS23R
• Device Catalogue Number: SGS23R
• Device Lot Number: 165-22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose