EEA
Received Sep 25, 2018 · Event occurred Jun 28, 2018
Report 2647580-2018-04697 · MDR key 7907992
Device
Generic name
Plate, Base, Shellac
Manufacturer
Us Surgical Puerto RicoModel number
TRIEEA28MTCatalog number
TRIEEA28MT
Lot number
P8A0976X
Product problems
- Difficult to Remove
- Difficult to Remove
Patient
66 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, ON ANASTOMOSIS OF THE RECTUM, IT WAS DIFFICULT TO REMOVE THE STAPLER FORM THE CAVITY. THE SURGEON HAD TO REMOVE THE INSTRUMENT BY INSERTING HIS FINGER RECTALLY AND ASSIST DIGITALLY TO REMOVE THE INSTRUMENT. THERE WAS NO PATIENT INJURY.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTAL RESECTION WITH ILEOSTOMY PROCEDURE, ON ANASTOMOSIS OF THE RECTUM, IT WAS DIFFICULT TO REMOVE THE STAPLER FROM THE CAVITY. THE SURGEON HAD TO REMOVE THE INSTRUMENT BY INSERTING HIS FINGER RECTALLY AND ASSIST DIGITALLY TO REMOVE THE INSTRUMENT. THERE WAS NO PATIENT INJURY.