MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-10 for OVERTUBE ENDOSCOPIC ACCESS SYSTEM OVT-027-160 manufactured by Apollo Endosurgery, Inc..
[174488935]
The inside of the tube was cracked, causing the device to not inflate and therefore, could not hold tube in place.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9574572 |
| MDR Report Key | 9574572 |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-12-09 |
| Report Date | 2019-12-17 |
| Date Reported to FDA | 2019-12-17 |
| Date Reported to Mfgr | 2020-01-10 |
| Date Added to Maude | 2020-01-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | OVERTUBE ENDOSCOPIC ACCESS SYSTEM |
| Generic Name | ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY |
| Product Code | FED |
| Date Received | 2020-01-10 |
| Model Number | OVT-027-160 |
| Catalog Number | OVT-027-160 |
| Lot Number | 1907-2009 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APOLLO ENDOSURGERY, INC. |
| Manufacturer Address | 1120 S CAPITAL OF TX HWY BLDG 1, STE 300 AUSTIN TX 78746 US 78746 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-10 |