FDA Adverse Event Malfunction Summary report: N

TITAN SGS

MDR report key: 17715430 · Received September 8, 2023

Report

Report Number: 3012481535-2023-00003
Event Type: Malfunction
Date Received: September 8, 2023
Date of Event: March 9, 2023
Report Date: August 28, 2023
Manufacturer: STANDARD BARIATRICS
Product Code: GDW
UDI-DI: 00851677007089
PMA / PMN Number: K210278
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AL, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

DUE TO THE LOAD ON THE FIRING SYSTEM, THE DEVICE PAUSED FIRING AND INSTRUCTED THE USER TO MANUALLY BAILOUT, WHICH IS AN INTENDED DESIGN FUNCTION OF THE DEVICE. DURING THE MANUAL BAILOUT, EXCESSIVE FORCE WAS APPLIED TO THE CLOSURE SCREW AND CAUSING IT TO BEND/DISTORT, AS OBSERVED DURING THE INVESTIGATION. THE DAMAGE TO THE CLOSURE SYSTEM LED TO THE DEVICE BEING INOPERABLE AND JAWS UNABLE TO BE CLOSED. 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.

Description of Event or Problem · 0

THE TITAN STAPLER HIT A CRITICAL LOAD DURING FIRING AS INDICATED BY AUDIBLE AND VISUAL CUES FROM THE SPU. BAILOUT PROCEDURE WAS INTIATED PER PROTOCOL (RETRACT BLADE AND OPEN JAWS). AFTER THE TISSUE WAS REMOVED FROM THE DEVICE, THE DEVICE COULD NOT BE CLOSED TO REMOVE FROM THE DEVICE FROM THE ABDOMINAL CAVITY. A LAPAROTOMY WAS REQUIRED TO REMOVE THE DEVICE FROM THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
712902	TITAN SGS	SURGICAL STAPLER WITH STAPLE, IMPLANTABLE, PRODUCT CODE: GDW	GDW	STANDARD BARIATRICS	SGS23R	087-22	00851677007089

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Required Intervention