GENERAL PURPOSE TEMPERATURE PROBE

Additional Manufacturer Narrative

INVESTIGATION FINDING: MANUFACTURING PLANT INSPECTED A TOTAL OF (B)(4) UNITS AND ALL PARTS WERE FOUND IN COMPLIANCE WITH THE PROCESS SPECIFICATIONS. PAST COMPLAINT LOGS HAVE BEEN REVIEWED AND CONFIRMED OF NO SIMILAR ISSUES HAVE BEEN REPORTED. ROOT CAUSE: NO ROOT CAUSE DETERMINED. THE SUS INVOLUNTARY REPORT (MW5100669) STATED THE FOLLOWING, "PATIENT WAS AGITATED IN ICU AND MAY HAVE BITTEN THROUGH THE WIRE." LOT INFORMATION PROVIDED BY THE CUSTOMER DOES NOT MATCH ANY OF THE COMPANY'S DEVICE HISTORY RECORDS (DOES NOT EXIST). THE INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

ACCORDING TO THE CUSTOMER A PIECE OF THE TEMPERATURE PROBE WAS BROKEN OFF AND FOUND INSIDE THE PATIENT STOMACH. PATIENT POTENTIALLY BIT OFF THE PROBE PER SUS VOLUNTARY EVENT REPORT (MW5100669). THE SUS VOLUNTARY EVENT REPORT STATED THE FOLLOWING: PATIENT COMPLAINS OF ABDOMEN DISTENTION AND NAUSEA. ABDOMEN WITHOUT PERITONITIS OR GUARDING. OBSTRUCTION SERIES SHOWS DILATED SMALL BOWL, AIR IN COLON CONCERN FOR ILEUS. BUT ALSO SHOWS A RETAINED OBJECT IN LUQ THAT IS CONCERNING FOR PORTION OF DOBHOFF TUBE (FEEDING TUBE) VS ESOPHAGEAL TEMP PROBE THAT APPEARS TO BE IN THE STOMACH. CHEST X-RAY SHOWED INTACT DOBHOFF COURSING THROUGH ESOPHAGUS INTO STOMACH GI CONSULTED FOR ESOPHAGOGASTRODUODENOSCOPY (EGD). EGD APPEARED TO BE A FRACTURED DOBHOFF TUBE IN THE BODY OF THE STOMACH THAT EXTENDED INTO THE ANTRUM AND INTO THE DUODENUM. SOME GASTRITIS WITH HEMATIN LIKELY FROM THE TRAUMA FROM THE PRESENCE OF A FOREIGN BODY IN THIS REGIN. PATHOLOGY REPORT OF A 0.3 CM IN DIAMETER RUBBERY TAN WHITE RUBBER COATED WIRE. SOUNDS LIKE THE ESOPHAGEAL PROBE. PATIENT WAS AGITATED IN ICU AND MAY HAVE BITTEN THROUGH THE WIRE.