FDA Adverse Event Injury Summary report: N

ETHICON

MDR report key: 23050494 · Received September 15, 2025

Report

Report Number
23050494
Event Type
Injury
Date Received
September 15, 2025
Date of Event
April 10, 2025
Report Date
August 8, 2025
Manufacturer
JOHNSON & JOHNSON
Product Code
GDW
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
OH
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

THE PATIENT PRESENTED TO ANOTHER FACILITY ON [DATE REDACTED] (POD 9) - [POST OPERATIVE DAY 9]) WITH ABDOMINAL PAIN, HIGH FEVER, TACHYCARDIA AND CT SCAN SUSPICIOUS FOR ANASTOMOTIC LEAK. PATIENT WAS IMMEDIATELY/EMERGENTLY TRANSPORTED VIA LIFE FLIGHT TO THIS HOSPITAL WHERE HE WAS TAKEN EMERGENTLY TO THE OPERATING ROOM FOR EXPLORATORY LAPAROTOMY CONVERTED TO OPEN, COLONIC ANASTOMOTIC RESECTION WITH END COLOSTOMY WITH NOTED STOOL IN THE LLQ [LEFT LOWER QUADRANT] AND A LARGE HOLE IN THE PRIOR ANASTOMOSIS. ALSO NOTED WERE BENT STAPLES AND UNFORMED STAPLES ALONG THE STAPLE LINE WITH THE HOLE. POSTOPERATIVELY, THE PATIENT WAS STARTED ON ZOSYN AND TRANSFERRED TO THE SICU [SURGICAL INTENSIVE CARE UNIT] IN CRITICAL CONDITION FROM SEVERE SEPSIS. PATIENT'S RECOVERY WAS SLOW WITH SIGNIFICANT TACHYCARDIA AND DELAY OF OSTOMY FUNCTION. COURSE C/B GI [COMPLICATED BY GASTROINTESTINAL] BLEED FROM NG [NASOGASTRIC] TUBE TRAUMA S/P EGD [STATUS POST ESOPHAGOGASTRODUODENOSCOPY] WITH CLIPS ON [DATE REDACTED] - TWO DAYS AFTER THIS HOSPITAL ADMISSION AND POD 11. INTERMITTENT FEVERS WITH SIRS [SYSTEMIC INFLAMMATORY RESPONSE SYNDROME] RESPONSE AND NOW S/P DRAIN PLACEMENT FOR PELVIC COLLECTION FOUND ON CT [DATE REDACTED] - DAY 4 OF ADMISSION TO THIS HOSPITAL. COURSE C/B POSTOPERATIVE ILEUS WITH DECREASED OSTOMY OUTPUT. BY POD 14, THE PATIENT WAS ABLE TO TOLERATE A SOLID DIET WITHOUT N/V [NAUSEA AND VOMITING], HAVE A RETURN OF BOWEL FUNCTION, AMBULATE AT BASELINE MOBILITY AND VOID INDEPENDENTLY. PATIENT WAS EVALUATED AS STABLE AND DISCHARGED TO HOME ON [DATE REDACTED] - TWO WEEKS AFTER ADMISSION TO THIS HOSPITAL. MANUFACTURER RESPONSE FOR J&J ETHICON STAPLER, ETHICON (PER SITE REPORTER). REEDUCATION AND OR VENDOR PRESENCE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2373126 ETHICON STAPLE, IMPLANTABLE GDW JOHNSON & JOHNSON

Patients

Seq Age Sex Outcome Treatment
1 42 YR Male Life Threatening| R| H