NI
Received Sep 10, 2014 · Event occurred Apr 22, 2014
Report 2183446-2014-00001 · MDR key 4080746
Device
Product problems
- Use of Device Problem
Patient
Not reported
- Perforation
Narrative
Additional Manufacturer Narrative
HOSPITAL WAS UNABLE TO PROVIDE EXACT PART NUMBER AND LOT NUMBER OF 24FR BOUGIE AND PART WAS NOT RETURNED FOR EVAL. A REVIEW OF SHIPMENT RECORDS TO THIS CUSTOMER SHOWS THE LIKELY DEVICE TO BE PART NUMBER 1208-24 AND LOT NUMBER 212841, SHIPPED ON (B)(4) 2012. THE BOUGIES ARE A REUSABLE DEVICES, LABELED WITH A 3 YEAR EXPIRATION DATE. PT ESOPHAGEAL PERFORATION WAS REPAIRED WITH 4 SUTURES DURING OPEN APPROACH OF HERNIA REPAIR PROCEDURE. PT DID NOT RECEIVE ANY ADDITIONAL TREATMENT. THERE WAS NO MALFUNCTION OF THE DEVICE AND THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE INJURY.
Description of Event or Problem
PT UNDERWENT REPAIR OF A LARGE INCARCERATED PARAESOPHAGEAL HERNIA. WHILE PASSING 24F BOUGIE DOWN ESOPHAGUS, A PERFORATION WAS NOTED. PROCEDURE WAS CONVERTED FROM LAPAROSCOPIC TO OPEN APPROACH.