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

Model Number 81-020409EU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

Root cause: the investigation identified the root cause as a use error in the placement of the probe.The probe is intended to be placed in the esophagus, but it is not intended to go into the stomach.Corrective action: a corrective action has not been taken.Investigation summary.An internal complaint ((b)(4)) was received indicating that a general purpose temperature probe (part number 81-020409eu, lot 44557628) was inserted through a patient's esophagus into the stomach where it was surgically stapled.The patient underwent a second surgery to remove the probe.A sample was not available for return; therefore, a visual inspection and evaluation could not be performed.The work order was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.The drawing was reviewed and it was confirmed the probe tubing was within the specified length.Additionally, incoming inspection documents of the tubing used in production of the reported lot confirmed that all total length results were within specification.Additionally, deroyal offers general purpose temperature probes with printed depth markings on the tubing that are placed every 5 centimeters.The instructions for use state the probe is intended to be placed in the nasal or nasopharynx cavities, into the esophagus, or into the rectum.Additionally, it states, to verify proper placement of a probe used in the esophagus, a laryngoscope should be used.A two-year review of complaints was completed and no similar events have been reported.Preventive action: a corporate corrective and preventive action ((b)(4)) has been opened to evaluate if all general purpose probes should show depth markings on the tubing.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

An end user insterted a general purpose temperature probe via the esophagus and into the stomach where it was attached to the scene by surgical stapling.The patient underwent a second surgery to release the probe from the gastric wall tissue.The end user suggested that the probe design was too long and the product quality may be increased by printing a numeric scale on the device.

• Brand Name: GENERAL PURPOSE TEMPERATURE 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 37849 ; 8653626112
• MDR Report Key: 7052593
• MDR Text Key: 93302218
• Report Number: 9613793-2017-00006
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K925791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 81-020409EU
• Device Lot Number: 44557628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2017
• 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