MAUDE Adverse Event Report: STANDARD BARIATRICS TITAN SGS; SURGICAL STAPLER WITH STAPLE, IMPLANATABLE, PRODUCT CODE: GDW

Model Number SGS23R

Device Problem Mechanical Problem (1384)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/08/2022

Event Type  malfunction  

Manufacturer Narrative

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 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 Description

During a sleeve gastrectomy procedure, at the beginning of firing mode, a high load was detected which ultimately led to the user requiring to engage in manual bailout of the titan sgs stapler.During manual bail out and using the bailout key provided, the user 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, as the bailout key spun freely, which resulted in requiring the trocar incision site to be slightly increased to allow for the removal of the titan sgs with the jaws in the open position.The procedure was prolonged, approximately 5 minutes, to remove the device.The procedure was completed using a different stapler.There was no additional patient consequence.

• Brand Name: TITAN SGS
• Type of Device: SURGICAL STAPLER WITH STAPLE, IMPLANATABLE, PRODUCT CODE: GDW
• Manufacturer (Section D): STANDARD BARIATRICS; 4362 glendale milford rd; cincinnati OH 45242
• Manufacturer Contact: michelle schnell ; 4362 glendale milford road; cincinnati, OH 45242 ; 5136207751
• MDR Report Key: 15370883
• MDR Text Key: 306163673
• Report Number: 3012481535-2022-00006
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 00851677007089
• UDI-Public: (01)00851677007089(17)230406(11)220406(10)103-22
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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: 08/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention