Brand Name | OVERTUBE ENDOSCOPIC ACCESS SYSTEM |
Type of Device | ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY |
Manufacturer (Section D) |
APOLLO ENDOSURGERY |
1120 s. capital of texas hwy |
bldg 1 suite 300 |
austin TX 78746 |
|
Manufacturer (Section G) |
ROSE TECHNOLOGIES COMPANY |
1440 front avenue nw |
|
grand rapids MI 49504 |
|
Manufacturer Contact |
carole
morley
|
300 boston scientific way |
marlborough, MA 01752
|
5086834015
|
|
MDR Report Key | 18959055 |
MDR Text Key | 338554145 |
Report Number | 3005099803-2024-01220 |
Device Sequence Number | 1 |
Product Code |
FED
|
UDI-Device Identifier | 20811955020708 |
UDI-Public | 20811955020708 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K122270 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/22/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/22/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | OVT-027-160 |
Device Lot Number | 2306-2049 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/22/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/14/2023 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |