MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. ESOPHAGEAL PROBE; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 81-020409

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Gastritis (1874); Nausea (1970); Abdominal Distention (2601); Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

On 2/10 pt c/o abd distention and nausea.Abdomen without peritonitis or guarding.Obstruction series shows dilated small bowel, air in colon concern for ileus.But also shows a retained object in luq that is concerning for portion of dobhoff tube vs esophageal temp probe that appears to be in the stomach.Cxr from 2/8 showed intact dobhoff coursing through esophagus into stomach gi consulted for egd and retrieval 2/11 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 region.Patho report- 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.Fda safety report id# (b)(4).

• Brand Name: ESOPHAGEAL PROBE
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC. ; powell TN 37849
• MDR Report Key: 11640932
• MDR Text Key: 244912202
• Report Number: MW5100669
• Device Sequence Number: 1
• Product Code: FLL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 81-020409
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 41 YR