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

Model Number	SGS23R
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The titan stapler hit a critical hard firing limit at about 50% firing after hitting a soft firing limit.The knife blade was retracted and the jaws of the device were opened, but when attempting to close the jaws, the silver coupler broke off.The jaws of the device were not able to be closed.The trocar incision was increased to remove the device from abdomen.
Additional Manufacturer Narrative
Upon evaluation of the titan sgs stapler, it was determined that the load applied to the closure screw was excessive and caused it to bend/distort as well as causing damage to the gear during the opening of the jaws of the stapler, as damage was observed.The investigation found that the damage to the closure system led to the device being inoperable.The root cause was attributed to excessive force/rotations being applied by the user to the closure system while attempting to manually open the jaws of the device using the bailout key, resulting in the device being stuck in the open position.
Additional Manufacturer Narrative
Following analysis of the complaint device, the findings were shared with the surgeon associated with the complaint.During the instructed bailout process, the surgeon did not feel that excessive force was applied to cause the damage and that if the design meets the manufacturer's current specifications, further investigations into the those specifications should be evaluated.

• Brand Name: TITAN SGS
• Common Device Name: SURGICAL STAPLER WITH STAPLE, IMPLANTABLE
• 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: 17719250
• Report Number: 3012481535-2023-00006
• Device Sequence Number: 20655226
• Product Code: GDW
• UDI-Device Identifier: 00851677007089
• UDI-Public: (01)00851677007089(17)240823(11)220823(10)208-22
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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: 08/23/2024
• Device Model Number: SGS23R
• Device Catalogue Number: SGS23R
• Device Lot Number: 208-22
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• 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