MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-05-12 for LEVEL 1? ESOPHAGEAL STETHOSCOPE TEMPERATURE SENSOR ES400-18 manufactured by Smiths Medical Asd, Inc..
[75045094]
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.
Patient Sequence No: 1, Text Type: N, H10
[75045095]
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.
Patient Sequence No: 1, Text Type: D, B5
[108187237]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012307300-2017-01047 |
| MDR Report Key | 6563648 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-12 |
| Date of Report | 2017-08-22 |
| Date of Event | 2015-11-18 |
| Date Mfgr Received | 2016-04-07 |
| Date Added to Maude | 2017-05-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JENNIFER MENG |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833078 |
| Manufacturer G1 | SMITHS HEALTHCARE MFG |
| Manufacturer Street | S.A. DE C.V. AVE CALIDAD NO. 4 PARQUE INDUSTRIAL INTERNACIONA |
| Manufacturer City | TIJUANA, 22425 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22425 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEVEL 1? ESOPHAGEAL STETHOSCOPE TEMPERATURE SENSOR |
| Generic Name | STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS |
| Product Code | BZT |
| Date Received | 2017-05-12 |
| Catalog Number | ES400-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-12 |