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

Model Number 81-020409

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2020

Event Type  malfunction  

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 Description

A temperature probe was found in the right mainstem bronchus during transesophageal temperature monitoring.

• Brand Name: GENERAL PURPOSE PROBE
• Type of Device: 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
• Manufacturer (Section G): DEROYAL CIENTIFICA DE LATINOAMERICA, S.R.L.; global park, box 180-3006; 602 parkway, la aurora; heredia, heredia 146 ; CS 146
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, tn ; 3626112
• MDR Report Key: 10431547
• MDR Text Key: 204219078
• Report Number: 9613793-2020-00001
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 00749756046145
• UDI-Public: 00749756046145
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 81-020409
• Device Lot Number: 61377975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 78