MAUDE Adverse Event Report: Standard Bariatrics Titan SGS 23cm Stapler Kit Sales Assembly; LAPAROSCOPY KIT

Catalog Number	SGS23KIT
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2026
Type of Reportable Event	Malfunction

• Brand Name: Titan SGS 23cm Stapler Kit Sales Assembly
• Common Device Name: LAPAROSCOPY KIT
• Manufacturer (Section D): Standard Bariatrics; cincinnati OH
• Manufacturer (Section G): Standard Bariatrics; 4300 glendale milford rd.; cincinnati OH 45242
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 50134574
• Report Number: 3012481535-2026-00004
• Device Sequence Number: 17542462
• Product Code: FDE
• UDI-Device Identifier: 14026704923523
• UDI-Public: (01)14026704923523(11)260113(17)270924(10)36A2600001
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/08/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: SGS23KIT
• Device Lot Number: 36A2600001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2026
• 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: Unknown