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	08/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The titan stapler hit a critical load after 2 high load warnings occurred.The jaws of the device were fully opened, but the manual bailout tissue was stuck distally.The surgeon continued to turn the bailout key and the closure coupler broke off.This led to the titan being stuck in the open position.The 19 port size was increased so the open titan could be removed.The patient is doing well.
Additional Manufacturer Narrative
Upon evaluation of the titan sgs, it was determined that the knife was not fully reversed prior to opening the jaws, as instructed in the device instructions for use.Consequently, the load applied to the closure screw was excessive and caused it to bend/distort as well as causing the observed damaged to the gear during the opening of the jaws of the titan stapler.The investigation found that the damage to the closure system led to the device being inoperable.The root cause was attributed to the knife not being fully reversed and excessive force/rotations being applied by the user to the closure system while attemping 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
• 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: 17831538
• Report Number: 3012481535-2023-00009
• Device Sequence Number: 12485238
• 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: MI
• 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): 09/26/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 09/28/2023
• 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