MALLINCKRODT
Received Sep 29, 2010 · Event occurred Jul 22, 2010
Report 2936999-2010-01222 · MDR key 1872641
Device
Generic name
Esophageal Stethoscope W/temp Senso
Manufacturer
Covidien/formerly Tyco HealthcareCatalog number
90042
Product problems
- Sticking
- Device Dislodged or Dislocated
Patient
34 YR
- Laceration(s)
Narrative
Description of Event or Problem
COVIDIEN RECEIVED ON 08/30/2010, (B)(4). IT WAS REPORTED THAT "DURING THE ESOPHAGOGASTRODUODENOSCOPY (EGD) PORTION OF A GASTRIC PACEMAKER IMPLANTATION CASE, THE TEMPERATURE PROBE OF THE ESOPHAGEAL STETHOSCOPE BECAME DISLODGED DISTALLY DOWN INTO THE STOMACH. UPON EXTRACTION OF THE TEMPERATURE PROBE, THE PROXIMAL TIP BECAME LODGED IN THE LEFT LATERAL WALL OF THE CERVICAL ESOPHAGUS JUST BELOW THE UPPER ESOPHAGEAL SPHINCTER. THE RETAINED TIP WAS REMOVED SUCCESSFULLY, BUT A SMALL LACERATION OF THE LEFT LATERAL CERVICAL ESOPHAGEAL WALL DID OCCUR." THE PATIENT'S STAY IN THE HOSPITAL WAS EXTENDED, SHE WAS GIVEN ADDITIONAL ANTIBIOTICS AS WELL.
Additional Manufacturer Narrative
THE LOT NUMBER IS UNKNOWN. WE ARE FOLLOWING UP WITH THE FACILITY FOR ADDITIONAL INFORMATION.