MAUDE Adverse Event Report: STANDARD BARIATRICS TITAN SGS RB STAPLER 23 CM

Catalog Number	SGS23RB
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "after the dissected stomach was removed, it was inflated and a leak along the staple line was noticed.Only the extracted portion of the stomach had this issue.It occurred roughly at the 50% mark of the stapler".The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "after the dissected stomach was removed, it was inflated and a leak along the staple line was noticed.Only the extracted portion of the stomach had this issue.It occurred roughly at the 50% mark of the stapler".The "patient's" current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as the sample and spu data were not returned for analysis.A device history record review was performed and no issues with the lot were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: TITAN SGS RB STAPLER 23 CM
• Common Device Name: TITAN SGS
• Manufacturer (Section D): STANDARD BARIATRICS; cincinnati
• Manufacturer (Section G): STANDARD BARIATRICS; 4300 glendale milford rd.; cincinnati
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23062255
• Report Number: 3012481535-2025-00013
• Device Sequence Number: 10044084
• Product Code: GDW
• UDI-Device Identifier: 00851677007133
• UDI-Public: (01)00851677007133(11)230213(17)260213(10)044-23(21)
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K210278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/13/2026
• Device Catalogue Number: SGS23RB
• Device Lot Number: 044-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2023
• 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
• Patient Sex: Female