FDA Adverse Event Injury Summary report: N

COVIDIEN-MEDTRONIC

MDR report key: 5483083 · Received March 2, 2016

Report

Report Number
MW5060763
Event Type
Injury
Date Received
March 2, 2016
Date of Event
March 10, 2015
Report Date
March 3, 2016
Manufacturer
COVIDIEN
Product Code
GCJ
Product Problem
Yes
Report Source
Voluntary report

Narratives

Description of Event or Problem · 1

ON (B)(6) 2015, A (B)(6) MALE UNDERWENT A V IDEO ASSISTED THORACOSCOPY ON THE RIGHT UTILIZING THE DA VINCI ROBOT, LYSIS OF ADHESIONS, COMPLETE LYMPH NODE DISSECTION AND RIGHT LOWER LOBECTOMY FOR A RIGHT LOWER LOBE LUNG MASS PRESENT ON CHEST X-RAY. HISTORY OF GOUT AND RECENT DIAGNOSIS OF LYMPHOCYTIC LEUKEMIA. UNEVENTFUL POST-OPERATIVE COURSE, LUNG BIOPSY POSITIVE FOR ADENOCARCINOMA, DISCHARGED HOME ON (B)(6) 2015. ON (B)(6) 2015 PRESENTS WITH A NONHEALING CHEST TUBE TRACT AND UNDERWENT AN EXPLORATION OF CHEST TUBE TRACT WITH EXCISION OF SINUS TRACT AND DEBRIDEMENT WITH PLACEMENT OF A WOUND VAC. ON (B)(6) 2016, PATIENT'S NONHEALING CHEST TUBE TRACT PERSISTS AND HE IS TAKEN TO THE OPERATING ROOM FOR EXPLORATION AND EXCISION OF FISTULOUS TRACT, PARTIAL EXCISION OF RIB AND REMOVAL OF FOREIGN BODY FROM THE CHEST WALL. DURING THE SURGERY, SURGEON DISCOVERS AND REMOVES A PIECE OF PLASTIC MEASURING 14.2 X 1.3 CM. THE FOREIGN BODY IS BELIEVED TO HAVE COME OFF THE ENDO CATCH SPECIMEN RETRIEVAL POUCH RING DURING THE (B)(6) 2015 SURGERY UNBEKNOWNST TO THE SURGEON AND OPERATING ROOM STAFF PRESENT IN THE ROOM. THE ENDO CATCH RING IS RETRACTED INTO THE TUBE WHEN REMOVED FROM THE PATIENT AND IS NOT VISIBLE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
131831 COVIDIEN-MEDTRONIC ENDO CATCH II SPECIMEN RETRIEVAL POUCH GCJ COVIDIEN

Patients

Seq Age Sex Outcome Treatment
1 61 YR Hospitalization