MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-03 for ESUCTION, ESOPHAGEAL ET2000 manufactured by Endo-therapeutics, Inc..
[173931708]
Presented with food bolus. Snare was used to attempt removal but was too small to encircle the bolus. An e-suction cap device was then applied to the tip of the scope. The scope was then advanced back into the cervical esophagus. The bolus was suctioned into the cap but the wire of the device failed and the cap dislodged on top of the food bolus. This was immediately below the upper esophageal sphincter. Provider was unable to remove this due to pt retching and risk of airway obstruction. Anesthesia was called and the pt was intubated and transferred to the ed with intention of transfer to a tertiary care facility where accepting ent removed the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092027 |
| MDR Report Key | 9552578 |
| Date Received | 2020-01-03 |
| Date of Report | 2019-12-30 |
| Date of Event | 2019-12-20 |
| Date Added to Maude | 2020-01-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESUCTION, ESOPHAGEAL |
| Generic Name | SNARE, NON-ELECTRICAL |
| Product Code | FGX |
| Date Received | 2020-01-03 |
| Model Number | ET2000 |
| Catalog Number | ET2000 |
| Lot Number | 336750 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDO-THERAPEUTICS, INC. |
| Manufacturer Address | 15251 ROSSEVELT BLVD STE 204 CLEARWATER FL 33760 US 33760 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-01-03 |