MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-26 for WATS3D BRUSH EGD-160-006 manufactured by Endo-therapeutics, Inc.
[137548794]
The patient, who has a history of long segment barrett? S esophagus (10-15 cm), underwent surveillance with upper endoscopy with forceps biopsy and brush biopsy. After the forceps biopsies were obtained, the brush biopsy was introduced into the channel of the endoscope. While the physician held the endoscope, the physician? S assistant moved the brush up and down to sample the esophagus. The esophagus was noted to be very tortuous, and at a segment of the esophagus, which was felt to be sharply angulated and not entirely visible on the monitor, the esophagus was perforated. The patient was admitted to the hospital and the following day, the perforation was surgically repaired. The patient recovered and was discharged several days later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084452 |
| MDR Report Key | 8374941 |
| Date Received | 2019-02-26 |
| Date of Report | 2019-02-22 |
| Date of Event | 2019-01-25 |
| Date Added to Maude | 2019-02-27 |
| 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 | 0 |
| Brand Name | WATS3D BRUSH |
| Generic Name | ESOPHAGEAL BIOPSY BRUSH |
| Product Code | GEE |
| Date Received | 2019-02-26 |
| Model Number | EGD-160-006 |
| Lot Number | 351132 |
| 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 | CLEARWATER FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-02-26 |