MAUDE Adverse Event Report: STANDARD BARIATRIC, INC. TITAN SGS; SURGICAL STAPLER WITH STAPLE, IMPLANTABLE

Model Number	SGS23R
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user reported that resistance was felt when trying to close the jaws of the titan sgs stapler, which is indicative of a bent closure screw prohibiting the manual bailout key from working.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 during the opening of the jaws of the titan sgs 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.
Event or Problem Description
During a sleeve gasrectomy procedure, at approximately 50% of firing, a high load was detected, which ultimately led to the user requiring to engage in manual bailout of the titan sgs stapler.During manual bailout and using the bailout key provided, the user successfully reset the knife and opened the jaws to remove the device from the stomach.When attempting to close the device using the manual bailout key, resistance was felt and the jaws were unable to be closed, requiring the trocar incision site to be slightly increased to allow for removal of the titan sgs with the jaws in the open position.The procedure was completed using a different stapler.There was no patient injury or consequence other than extension of the surgical incision.

• Brand Name: TITAN SGS
• Common Device Name: SURGICAL STAPLER WITH STAPLE, IMPLANTABLE
• Manufacturer (Section D): STANDARD BARIATRIC, INC.; 4362 glendale milford road; cincinnati OH 45242
• Manufacturer Contact: michelle schnell ; 4362 glendale milford road; cincinnati, OH 45242 ; 5136207751
• MDR Report Key: 15372254
• Report Number: 3012481535-2022-00005
• Device Sequence Number: 1636160
• Product Code: GDW
• UDI-Device Identifier: 00851677007089
• UDI-Public: (01)00851677007089(17)230406(11)220406(10)103-22
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K210278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 09/07/2022

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: 04/06/2023
• Device Model Number: SGS23R
• Device Catalogue Number: SGS23R
• Device Lot Number: 103-22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (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