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

Model Number	SGS23RB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient developed a leak on (b)(6) 2023 following a sleeve gastrectomy procedure completed on (b)(6) 2023, which had used a titan sgs23rb stapler.A small defect was observed more posterior of the fundus.It was reported that it looked like the fundus was possibly folded.Re-operation/surgical intervention was required to resolve the leak.The patient was released after re-operation/surgical intervention.Standard bariatrics was informed of the leak 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: 16882147
• Report Number: 3012481535-2023-00002
• Device Sequence Number: 15269408
• Product Code: GDW
• UDI-Device Identifier: 00851677007133
• UDI-Public: 00851677007133
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• 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: 10/11/2023
• Device Model Number: SGS23RB
• Device Catalogue Number: SGS23RB
• Device Lot Number: 284-22
• 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: 10/11/2022
• 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: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose