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

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	07/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The titan stapler hit a critical high load after consistent high load warnings occured.The bailout process was initiated by a resident and nearly completed successfully.The remaining portion of the procedure was completed with an ethicon stapler.When the resident tried to close the stapler using the bailout key, the silver knob dropped out of the stapler.The surgeon used bovie and towel clamp to get open stapler out of abdomen, as well as increasing the trocar incision.The patient is doing well.A leak test was performed with no signs of a leak.
Additional Manufacturer Narrative
Upon evaluation of the titan sgs, 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 titan 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.

• Brand Name: TITAN SGS
• Common Device Name: SURGICAL STAPLER WITH STAPLE, IMPLANTABLE, PRODUCT CODE: GDW, PRODUCT CODE: GDW
• Manufacturer (Section D): STANDARD BARIATRICS; 4300 glendale milford rd.; cincinnati OH 45242
• Manufacturer Contact: tony yux ; 4300 glendale milford rd.; cincinnati, OH 45242 ; 5136207751
• MDR Report Key: 17720544
• Report Number: 3012481535-2023-00007
• Device Sequence Number: 7163213
• Product Code: GDW
• UDI-Device Identifier: 00851677007089
• UDI-Public: (01)00851677007089(17)240928(11)220928(10)271-22
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2023

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
• Device Expiration Date: 09/28/2024
• Device Model Number: SGS23R
• Device Catalogue Number: SGS23R
• Device Lot Number: 271-22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• 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: Prefer Not To Disclose