MAUDE Adverse Event Report: STANDARD BARIATRICS TITAN SGS; SURGICAL STAPLER WITH STAPLE

Model Number	SGS23R
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
After the staple line was completed using the titan stapler, the jaws could not be opened with trigger up.The surgeon then attempted to manually bail out.The jaws were able to be opened slightly, but the closure coupler came loose and fell out of the device.The jaws couldn't be opened further, although, the opening was large enough to remove the stomach from between the jaws.Multiple attempts were made unsuccessfully to place the coupler back into place.Forceps were then used to expand the trocar incision site for titan extraction.Extraction was successful and the titan stapler was able to be removed.Cautery was applied and port site was closed.

• Brand Name: TITAN SGS
• Common Device Name: SURGICAL STAPLER WITH STAPLE
• Manufacturer (Section D): STANDARD BARIATRICS; 4300 glendale milford rd; cincinnati OH 45242
• Manufacturer Contact: tony yux ; 4300 glendale milford rd; cincinnati, OH 45242
• MDR Report Key: 19444267
• Report Number: 3012481535-2024-00003
• Device Sequence Number: 8785538
• Product Code: GDW
• UDI-Device Identifier: 00851677007089
• UDI-Public: (01)00851677007089(17)240727(11)220727(10)194-22
• 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: 2024
• 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): 05/29/2024

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 Expiration Date: 07/27/2024
• Device Model Number: SGS23R
• Device Catalogue Number: SGS23R
• Device Lot Number: 194-22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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
• Patient Sex: Unknown