FDA Adverse Event Injury Summary report: N

TITAN SGS

MDR report key: 17479165 · Received August 8, 2023

Report

Report Number
17479165
Event Type
Injury
Date Received
August 8, 2023
Date of Event
June 21, 2023
Report Date
August 4, 2023
Manufacturer
STANDARD BARIATRICS
Product Code
GDW
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
MA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

THE PATIENT IS A MIDDLE AGE, ENGLISH SPEAKING FEMALE CAUCASIAN WITH A PAST MEDICAL HISTORY OF MORBID OBESITY COMPLICATED BY DIABETES, OSA, AND FATTY LIVER. ON [REDACTED DATE], SHE UNDERWENT A LAP (LAPAROSCOPY), SLEEVE GASTRECTOMY, HIATAL HERNIA REPAIR, AND LIVER BIOPSY. PER THE OPERATIVE NOTE: A TITAN SGS 23CM SINGLE FIRE CARTRIDGE STAPLER WAS THEN INTRODUCED INTO THE ABDOMEN. THE CLAMP WAS OPENED, AND THE MOBILIZED GREATER CURVE WAS INTRODUCED INTO THE CLAMP. THE STAPLER WAS THEN POSITIONED 1CM FROM THE GE JUNCTION, 3CM FROM THE INSICURA, AND 5CM FROM THE PYLORUS WHICH HAD BEEN PREVIOUSLY MEASURED WITH AN INTRACORPOREAL RULER AND MARKING PEN. AFTER CONFIRMING WITH ANESTHESIA THAT THE VISIG BOUGIE SLID ALONG THE LENGTH OF THE GREATER CURVE WITHOUT RESISTANCE OR TORQUE AND ENSURING THAT THERE WAS NOTHING ELSE IN THE STOMACH, THE STAPLER WAS ACTIVATED. THE STAPLER WAS PAUSED AT THE INITIAL CLOSURE, 25%, 50% AND 75% DISTANCE FIRINGS TO ALLOW FOR TISSUE COMPRESSION. WITH THE STAPLE LINE COMPLETE, THE STAPLER WAS OPENED AND REMOVED FROM THE ABDOMEN. THE STAPLE LINE ALONG THE LENGTH OF THE SLEEVE WAS FOUND TO BE WELL FORMED, STRAIGHT, AND HEMOSTATIC. THE VISIG TUBE WAS THEN TAKEN OFF SUCTION, AND LAPAROSCOPICALLY A SOFT BOWEL CLAMP WAS PLACED ACROSS THE PYLORUS. THE TUBE WAS THEN INSUFFLATED WITH 120CC OF DILUTE METHYLENE BLUE BY THE ANESTHESIA TEAM. THE ENTIRE STAPLE LINE WAS COVERED IN STERILE SURGICAL SPONGES TO PERFORM THE LEAK TEST. THE SPONGES WERE REMOVED FROM THE ABDOMINAL CAVITY AND INSPECTED ON THE BACK TABLE FOR EVIDENCE OF LEAK; THE LEAK TEST WAS NEGATIVE. TWO INTERRUPTED 2-0 VICRYL PEXY SUTURES WERE PLACED ALONG THE LOWER 2/3 AND 1/3 ALONG THE LENGTH OF THE STAPLE LINE TO THE RETROPERITONEAL FAT TO SUPPORT THE SLEEVE HEALING IN A STRAIGHT CONFIGURATION. THE PATIENT'S POST-OPERATIVE COURSE WAS UNEVENTFUL, AND SHE WAS DISCHARGED TO HOME ON [REDACTED DATE]. SHE WAS TRANSFERRED TO [REDACTED NAME] FROM AN OUTSIDE HOSPITAL, HOWEVER, ON [REDACTED DATE]. SHE PRESENTED THERE WITH A 2-DAY HISTORY OF SEVERE EPIGASTRIC PAIN. WORK UP REVEALED A STAPLE LINE LEAK. FURTHER WORKUP AT [REDACTED NAME], INCLUDING AN UPPER ENDOSCOPY SHOWED A LARGE PROXIMAL STAPLE LINE DEHISCENCE, APPROXIMATELY 4CM LONG, STARTING AT 40CM FROM INCISORS, GE JUNCTION AT 38CM FROM INCISORS. TREATMENT THUS FAR HAS BEEN AS FOLLOWS: IR DRAIN PLACED IN ABDOMINAL FLUID COLLECTION [REDACTED DATE]. PICC PLACED AND TPN INITIATED [REDACTED DATE]. ENDOVAC PLACEMENT [REDACTED DATE] - REMOVED [REDACTED DATE] WITH SUBSEQUENT ENDOSCOPIC STENT PLACEMENT X4. REMOVAL OF 1 WALL STENT [REDACTED DATE] (3 STENTS REMAIN IN PLACE). THE PLAN IS TO DISCHARGE TO HOME [REDACTED DATE] WITH SERVICES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
773149 TITAN SGS STAPLE, IMPLANTABLE GDW STANDARD BARIATRICS

Patients

Seq Age Sex Outcome Treatment
1 17520 DA Female Hospitalization