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 ESOPHAGEAL BIOPSY BRUSH EGD-160-006 manufactured by Endo-therapeutics, Inc..
[137549271]
The patient underwent hernia repair and a nissen fundoplication followed immediately with upper endoscopy esophageal screening and brush biopsy testing. The hernia repair had been delayed for 5 years in this patient. After the physician used the brush to collect the esophageal specimen, a tiny perforation was noted in the esophagus. The physician noted that the esophageal tissue was extremely friable and thin, and attributed these changes to chronic systemic steroid use to control rheumatoid arthritis, which made this patient very susceptible to perforation. The patient did not undergo sampling with forceps biopsy. The physician immediately repaired the defect with simple closure and a follow-up barium swallow the next day did not show any leakage or defect. The patient completely recovered and was discharged without any sequela.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084447 |
| MDR Report Key | 8374883 |
| Date Received | 2019-02-26 |
| Date of Report | 2019-02-22 |
| Date of Event | 2018-08-24 |
| 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 ESOPHAGEAL BIOPSY BRUSH |
| Generic Name | BRUSH, BIOPSY, GENERAL AND PLASTIC SURGERY |
| Product Code | GEE |
| Date Received | 2019-02-26 |
| Model Number | EGD-160-006 |
| Lot Number | 323358 |
| 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 |