InjuryFAT
MEDOVATION ESOPHAGEAL DILATOR
Received Mar 30, 1999 · Event occurred Mar 3, 1999
Report 218667 · MDR key 218667
Device
Generic name
Mahoney Dilator #58
Manufacturer
MedovationsModel number
121058Catalog number
*
Lot number
6/93
Product problems
- Unknown (for use when the device problem is not known)
Patient
44 YR
- Surgery, prolonged
- Chronic Obstructive Pulmonary Disease (COPD)
- Laparotomy
- Perforation of Esophagus
- Surgical procedure, additional
Narrative
Description of Event or Problem
PT HAD LAPAROSCOPIC NISSEN FUNDOPLICATION WHICH CONVERTED TO A LAPAROTOMY DUE TO ESOPHAGEAL PERFORATION AFTER INTRA-OPERATIVE DILATION. THE PT HAD DILATORS PASSED IN A GRADED FASHION STARTED WITH 48 TO 58. FIFTY-SIX WAS PASSED EASILY INTO THE ESOPHAGUS INTO THE STOMACH. WHEN SIZE 58 DILATOR WAS PASSED THE TIP OF THE DILATOR PERFORATED THE ESOPHAGUS IN THE POSTERIOR WALL ON THE RIGHT SIDE. DURING THE LAPAROTOMY THE REPAIR WAS PERFORMED ON THE ESOPHAGUS. GASTROSTOMY AND FEEDING JEJUNOSTOMY WERE ALSO INSERTED.