MAUDE Adverse Event Report: TELEFLEX MEDICAL TITAN SGS RB STAPLER 23 CM; SURGICAL STAPLER WITH STAPLE

Model Number	IPN928803
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Exsanguination (1841)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that the patient "suffered significant bleeding from the suture line" and "went into hemorrhagic shock during the night, forcing the surgeons to perform an emergency procedure to put a stop to the bleeding.We didn't witness any evident product malfunction or misuse during the trial".
Event or Problem Description
It was reported that the patient "suffered significant bleeding from the suture line" and "went into hemorrhagic shock during the night, forcing the surgeons to perform an emergency procedure to put a stop to the bleeding.We didn't witness any evident product malfunction or misuse during the trial".
Additional Manufacturer Narrative
Qn# (b)(4).The reported complaint of "post-operative bleed" could not be fully confirmed and linked to a manufacturing issue.This is because the device was not returned for investigation.No visual inspection could be performed.The spu data was reviewed for the completed surgery of the complaint sample.The data did not reveal any defects or malfunctions of the device.It is necessary to receive the physical sample to perform a proper investigation, determine root cause, and implement corrective actions.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: SURGICAL STAPLER WITH STAPLE
• 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: 22648104
• Report Number: 3012481535-2025-00008
• Device Sequence Number: 18295088
• 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: 07/29/2025
• 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