Brand Name | OVERSTITCH¿ ENDOSCOPIC SUTURING SYSTEM |
Type of Device | ENDOSCOPIC SUTURING SYSTEM |
Manufacturer (Section D) |
APOLLO ENDOSURGERY, INC |
1120 s. captail of texas hwy |
bldg 1, ste 300 |
austin 78746 |
|
Manufacturer (Section G) |
APOLLO ENDOSURGERY COSTA RICA, SRL |
coyol free zone |
building b 13.3 |
alajuela, cs CRI |
CS
CRI
|
|
Manufacturer Contact |
adriana
russell
|
1120 s. captail of texas hwy |
bldg 1, ste 300 |
austin 78746
|
5122795114
|
|
MDR Report Key | 17019922 |
MDR Text Key | 317465729 |
Report Number | 3006722112-2023-00122 |
Device Sequence Number | 1 |
Product Code |
OCW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K081853 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Literature,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
05/12/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/30/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 05/12/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
Patient Outcome(s) |
Required Intervention;
Hospitalization;
|