MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1® ESOPHAGEAL STETHOSCOPE TEMPERATURE SENSOR; STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS

Catalog Number	ES400-18
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/18/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that a level 1® esophageal stethoscope temperature sensor migrated into the patient's stomach.The patient was undergoing a laparoscopic gastric sleeve surgery at the time of the event.While the doctor was stapling the stomach (as a part of the gastric sleeve surgery), the doctor stapled over the esophageal stethoscope temperature sensor; stapling the device into the patient's stomach.To correct this, the patient's surgery had to be converted to an "open" procedure, requiring a full opening of the patient's abdomen.The event itself was determined to be an operator error.It was reported that there were no further clinical consequences to the patient.

• Brand Name: LEVEL 1® ESOPHAGEAL STETHOSCOPE TEMPERATURE SENSOR
• Common Device Name: STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6563648
• Report Number: 3012307300-2017-01047
• Device Sequence Number: 13473193
• Product Code: BZT
• UDI-Device Identifier: 10695085000327
• UDI-Public: 10695085000327
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K854212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ES400-18
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/07/2016
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 08/22/2017
• 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: 63 YR
• Patient Weight: 118