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

Model Number	SGS23R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Abdominal Pain (1685); Fluid Discharge (2686)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, a small leak at the ge junction was confirmed via ct scan for a patient who showed up at the er with abdominal pain.The patient had received a laparoscopic sleeve gastrectomy, which used the titan sgs23r stapler, approximately two weeks prior to the event.The patient was hospitalized, given fluids along with getting a perc drain.A stent was placed.

• Brand Name: TITAN SGS
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): STANDARD BARIATRICS, INC; 4362 glendale milford rd; cincinnati OH 45242
• Manufacturer Contact: michelle schnell ; 4362 glendale milford road; cincinnati, OH 45242 ; 5136207751
• MDR Report Key: 15157098
• Report Number: 3012481535-2022-00002
• Device Sequence Number: 5183808
• Product Code: GDW
• UDI-Device Identifier: 00851677007089
• UDI-Public: (01)00851677007089(17)230310(11)2203(10)10077-22
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2022

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: 03/10/2023
• Device Model Number: SGS23R
• Device Catalogue Number: SGS23R
• Device Lot Number: 077-22
• 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: 07/11/2022
• Initial Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• 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