MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. ESOPHAGEAL STETHOSCOPE, 400 SERIES REGULAR TUBE W/ TEMPERATURE SENSOR

Catalog Number 81-040412

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

The defective device was returned to the manufacturing facility for evaluation.The investigation is incomplete at this time.This report will be updated when new and critical information becomes available.

Event Description

An esophageal stethoscope was in use in the esophagus during surgery.The doctor stated the device read 2 degrees above "real." because the body temperature was high, the patient was moved to the icu and measured the body temperature with an ear thermometer.The doctor found there was a 2 degree difference between the est and the real one.This was the first occurrence, but another case of "2 degrees lower than real" occurred.

Manufacturer Narrative

Root cause analysis: after investigation and evaluation of the returned sample, the root cause is determined to be a failure to follow internal manufacturing procedures at either the grinding or testing operations.A resistance test was performed on the defective sample, which confirmed the device was 100 ohms below specification (1,344 to 1,366 ohms).It is possible the testing operator failed to catch a defective unit due to focusing only on the last two digits of the multimeter screen.Corrective action and/or systemic correction action taken: retraining of the relevant internal manufacturing procedures ((b)(4) - grind in manufacturing procedure and (b)(4)- testing procedure for thermistor wire sets) was performed with all grinding and testing operators to reinforce what to do if a product is out of specification.Additionally, an awareness communication was distributed to the same personnel to request their help to avoid recurrence of this issue.Investigation summary: the defective sample was returned to the manufacturing facility where a resistance test was performed.The device's resistance tested at 1,258 ohms, which is below specification.During the manufacturing testing operation, units are tested for a resistance of 1,344 to 1,366 ohms.The resistance specification is indicated on the sub-assembly drawing.The housing cap of the defective sample was removed to confirm the chip was grinded and no insulation failures were present.Refer to the attached photo.The procedures for the testing and grinding operations were reviewed, and it was confirmed both contain clear and correct instructions about what to do if product is found out of specifications.Because a lot number was not reported, it was not possible to review the device history record.However, the equipment log sheets, internal complaints, and material review reports were reviewed.* equipment log sheets - it was confirmed that four multimeters were found out of tolerance during calibration in the last four months.Investigations were performed and documented appropriately discarding any potential risk in the product.* internal complaints - internal complaints received in the last 12 months were reviewed for similar complaints.No previous reports of inaccurate temperature readings were identified for this product (part number 81-040412).* material review reports (mrrs) - mrrs for the last 12 months were reviewed.It was confirmed that no mrrs generated in the last 12 months involved the finished good sub-assembly (part number 74-10044).The failure mode effects and criticality analysis (fmea) was reviewed as part of the investigation.The failure mode of "obvious wrong temperature reading" with failure causes of "wrong chip type" or "insulation failure" were identified as possibly being associated to this complaint.As part of this investigation and taking into account the resistance reading during functional testing, the following two causes were initially considered: * expired device (cannot be confirmed because the lot number was not reported) * wrong chip type (dismissed due to the current receiving and qc incoming inspection controls) preventive action: a preventive action is not being taken because this is considered an isolated event.The investigation is complete.If new and critical information is received, this report will be updated.

Event Description

An esophageal stethoscope was in use in the esophagus during surgery.The doctor stated the device read 2 degrees above "real." because the body temperature was high, the patient was moved to the icu and measured the body temperature with an ear thermometer.The doctor found there was a 2 degree difference between the est and the real one.This was the first occurrence, but another case of "2 degrees lower than real" occurred.

• Brand Name: ESOPHAGEAL STETHOSCOPE, 400 SERIES REGULAR TUBE W/ TEMPERATURE SENSOR
• Type of Device: ESOPHAGEAL STETHOSCOPE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; global park, p.o. box 180-3006; 602 parkway; la aurora, heredia 146 ; CS 146
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; global park, p.o. box 180-3006; 602 parkway; la aurora, heredia 146 ; CS 146
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37909 ; 8653626112
• MDR Report Key: 5174048
• MDR Text Key: 29212496
• Report Number: 9613793-2015-00010
• Device Sequence Number: 1
• Product Code: BZT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K925789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 81-040412
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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