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	09/07/2022
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 as the design is intended to work.Based on the complaint description, the surgeon did not follow sequence of manual bailout directions, as noted in the titan stapler ifu, l0015.The knife shall be returned to the start position prior to opening the jaws.In this case, the jaws were opened first and damage to the closure system was reported by the user.This likely occurred due to excessive load being applied to the closure system.The complaint device was scrapped after the procedure.Therefore, the investigation was based only on the complaint description, communication with user, and associated spu data provided.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
A laparoscopic sleeve procedure was being completed on a patient with an unusually thick stomach.According to the surgeon, the surgeon had trouble closing the jaws of the device on the stomach.Upon firing, he received "high load detected".The surgeon then proceeded to manually fire device and encountered 1 more "high load detected" at 50% complete.The "bail out" audio prompt was heard, and the surgeon proceeded to manually bail out the device.Surgeon used the bail out chuck key on top gear first mistakenly and broke top gear and then he proceeded to reset knife blade.According to the surgeon, after the titan sgs device was opened, the surgeon could not close the device.As a result, the surgeon had to increase skin incision and remove device and trocar all at once.A lexington medical stapler was used to finish the sleeve with x5 reloads (60mm).Surgery was completed and an extra stitch in fascia due to the trocar site incision increase.No additional patient consequence or issue reported.

• Brand Name: TITAN SGS
• Common Device Name: SURGICAL STAPLER WITH STAPLE, IMPLANTABLE, PRODUCT CODE: GDW
• Manufacturer (Section D): STANDARD BARIATRICS; 4362 glendale milford road; cincinnati OH 45242
• Manufacturer Contact: michelle schnell ; 4362 glendale milford road; cincinnati, OH 45242 ; 5136207751
• MDR Report Key: 15544722
• Report Number: 3012481535-2022-00007
• Device Sequence Number: 5685106
• Product Code: GDW
• UDI-Device Identifier: 00851677007089
• UDI-Public: (01)00851677007089(17)230504(11)220504(10)125-22
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/05/2022

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
• Device Expiration Date: 05/04/2023
• Device Model Number: SGS23R
• Device Catalogue Number: SGS23R
• Device Lot Number: 125-22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2022
• 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