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	03/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a sleeve gastrectomy procedure, the allowable time for firing was exceeded for the titan sgs system which prompted the user to manually bail out the device.Complete stomach resection was achieved successfully prior to the time limit being exceeded.During manual bail out and using the bailout key provided, the user reset the knife, and was able to open the titan sgs jaws to release from the stomach.The user was unable to close the device using the bailout key, which resulted in requiring the trocar incision site to be increased approximately 1.5-2 inches to allow for the removal of the titan sgs with the jaws in the open position.There was a delay in procedure, approximately 10-15 minutes, but no patient injury or consequence other than extension of surgical incision < 2 inches.
Additional Manufacturer Narrative
The device was returned to standard bariatrics for evaluation.Investigation found that there was damage to the closure system which led to the device being inoperable.The root cause was attributed to excessive force being applied by the user to the closure system while attempting to manually open 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; 4362 glendale milford rd; cincinnati OH 45242
• Manufacturer Contact: michelle schnell ; 4362 glendale milford rd; cincinnati, OH 45242 ; 5136207751
• MDR Report Key: 14102630
• Report Number: 3012481535-2022-00001
• Device Sequence Number: 4805218
• Product Code: GDW
• UDI-Device Identifier: 00851677007089
• UDI-Public: (01)00851677007089(17)221222(11)211222(10)352-21
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K210278
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• 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): 04/13/2022

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: 12/22/2022
• Device Model Number: SGS23R
• Device Catalogue Number: SGS23R
• Device Lot Number: 352-21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2021
• 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