MAUDE Adverse Event Report: TELEFLEX MEDICAL TITAN SGS RB STAPLER 23 CM

Model Number	IPN928803
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "patient had a significant hemoglobin loss (6 points overall) but is stable right now.We didn't witness any evident product malfunction or misuse during the trial".
Event or Problem Description
It was reported "patient had a significant hemoglobin loss (6 points overall) but is stable right now.We didn't witness any evident product malfunction or misuse during the trial".
Additional Manufacturer Narrative
(b)(4).The reported complaint of "post-operative bleed" could not be fully confirmed based on the information provided.Complaint verification testing could not be performed as no sample was returned for analysis.The spu data for the surgery was reviewed as a part of this investigation.The spu data for the surgery was reviewed as a part of this investigation.There were four repeated instances of "open over current" recorded in the pre-fire clamp mode data.The "open over current" reading in the pre-fire clamp mode indicated the user attempted to open the device in the trocar.This action points to potential user error.It was concluded by r & d that the "open over current" reading is unlikely to be related to a mechanical issue inside the stapler as the device was able to be fully opened and closed several times throughout this case without issue.Corrective action is not required at this time as the probable cause could not be determined based upon the information provided and without a sample.A dhr review was performed with no evidence to suggest a manufacturing related cause.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: TITAN SGS RB STAPLER 23 CM
• Common Device Name: TITAN SGS
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): STANDARD BARIATRICS; 4300 glendale milford rd.; cincinnati
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22738775
• Report Number: 3012481535-2025-00009
• Device Sequence Number: 7125388
• Product Code: GDW
• UDI-Device Identifier: 00851677007133
• UDI-Public: (01)00851677007133(11)240514(17)270514(10)135-24-E(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K210278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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 Model Number: IPN928803
• Device Catalogue Number: SGS23RB
• Device Lot Number: 135-24-E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown