MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA, S.R.L. GENERAL PURPOSE PROBE; THERMOMETER, ELECTRONIC, CLINICAL

Model Number	81-020409
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: after investigation, it was determined the reported issue was due to use error.The product is intended to be used in the esophagus or rectum.Additionally, there is a warning in the instructions for use packaged with the product that "tracheal or bronchial insertion of the probe may cause airway obstruction and may be fatal if uncorrected." corrective action: a corrective action has not been taken due to the root cause determination.A medwatch report was received indicating a general purpose probe (part 81-020409) was found in the right mainstem bronchus during a transesophageal temperature monitoring.The defective device was not returned for evaluation.The reported lot number is not recognized by deroyal; therefore, no work order review could be performed.Product in process was not inspected.None of the potential defects that may appear during the regular manufacturing process are related to the reported issue.The device is intended to be used in the esophagus or rectum.This is identified in the instructions for use, which are packaged with the product.Additionally, the instructions for use also contain the following warning, " tracheal or bronchial insertion of the probe may cause airway obstruction and may be fatal if uncorrected." in the past two years, deroyal has received two internal complaints for the reported part number.However, neither of these complaints was related to the reported issue.The investigation is complete at this time.If new or critical information is received, this report will be updated.
Event or Problem Description
A temperature probe was found in the right mainstem bronchus during transesophageal temperature monitoring.

• Brand Name: GENERAL PURPOSE PROBE
• Common Device Name: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA, S.R.L.; global park, box 180-3006; 602 parkway, la aurora; heredia, heredia 146 ; CS 146
• MDR Report Key: 10431547
• Report Number: 9613793-2020-00001
• Device Sequence Number: 13919594
• Product Code: FLL
• UDI-Device Identifier: 00749756046145
• UDI-Public: 00749756046145
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K925791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 81-020409
• Device Lot Number: 61377975
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 78