MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. DEROYAL GENERAL PURPOSE PROBE 12FR; THERMOMETER, ELECTRONIC, CLINICAL

Catalog Number 81-020412

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

Patient Problems Injury (2348); Patient Problem/Medical Problem (2688); Full thickness (Third Degree) Burn (2696)

Event Date 04/16/2016

Event Type  Injury  

Manufacturer Narrative

Root cause: based on information received from the reporting customer, the root cause has been identified as improper use of the device.Corrective action: the risk analysis will be reviewed to ensure the failure mode and effect to the patient are represented.The instructions for use will also be revised for clarity to ensure safe and effective use.Investigation summary: an internal complaint (b)(4) was received reporting that a general purpose probe (part number 81-020412) was used on a patient during an mri procedure.After which, the patient received a third-degree burn near the armpit.A lot number was not reported and the device was unavailable for evaluation.In an email communication received 4/21/2016, the reporting customer stated the probe connector end was placed under the patient's right arm pit and the tip of the probe "wrapped up" around the neck "to the left side of the head in the occipital area." the instructions for use (part 74-14906, revision 6/10) packaged with part number 81-020412 state that the probe is intended to be used for "routine monitoring of temperature in anesthetized patients by inserting the probe into the esophagus or the rectum." without a sample or a reported lot number, a physical analysis and device history record review could not be performed.A review was performed of the last two work orders for part number 81-020412.No discrepancies or rejects were found during the manufacturing process.As part of the manufacturing process, a 100 percent electric leak test is performed to ensure that all products are in compliance from a functional standpoint.Any defective units are immediately scrapped.Action point and material release report logs were reviewed.No similar situations have been reported.Preventive action: no preventive actions have been identified as part of this investigation.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

A patient went in for an mri due to the possibility of a stroke.The patient was incoherent at the time of the mri.A general purpose temperature probe was in use during the procedure.The probe connector end was under the patient's right arm pit area.The tip of the probe was wrapped around the neck to the left side of the head in the occipital area.The patient received an electrical burn under the right arm near her armpit.The burn is third-degree.The patient family feels they see a burn mark on the left side of her scalp.

• Brand Name: DEROYAL GENERAL PURPOSE PROBE 12FR
• 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 37849 ; 8653626112
• MDR Report Key: 5599223
• MDR Text Key: 43369118
• Report Number: 9613793-2016-00002
• Device Sequence Number: 1
• Product Code: FLL
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 81-020412
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2016
• 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): Other