MAUDE Adverse Event Report: STANDARD BARIATRICS TITAN SGS; SURGICAL STAPLER WITH STAPLE, IMPLANTABLE, 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	03/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the load on the firing system, the device paused firing and instructed the user to manually bailout, which is an intended design function of the device.During the manual bailout, excessive force was applied to the closure screw and causing it to bend/distort, as observed during the investigation.The damage to the closure system led to the device being inoperable and jaws unable to be closed.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
The titan stapler hit a critical load during firing as indicated by audible and visual cues from the spu.Bailout procedure was intiated per protocol (retract blade and open jaws).After the tissue was removed from the device, the device could not be closed to remove from the device from the abdominal cavity.A laparotomy was required to remove the device from the patient.

• Brand Name: TITAN SGS
• Common Device Name: SURGICAL STAPLER WITH STAPLE, IMPLANTABLE, 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: 17715430
• Report Number: 3012481535-2023-00003
• Device Sequence Number: 2226393
• Product Code: GDW
• UDI-Device Identifier: 00851677007089
• UDI-Public: (01)00851677007089(17)230711(11)220711(10)087-22
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 08/28/2023

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: 07/11/2023
• Device Model Number: SGS23R
• Device Catalogue Number: SGS23R
• Device Lot Number: 087-22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2022
• 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