Brand Name | ENDO STITCH |
Type of Device | ENDOSCOPIC TISSUE APPROXIMATION DEVICE |
Manufacturer (Section D) |
DAVIS & GECK CARIBE LTD |
zona franca de san isidro |
santo domingo 0101 |
DO 0101 |
|
Manufacturer (Section G) |
DAVIS & GECK CARIBE LTD |
zona franca de san isidro |
|
santo domingo 0101 |
DO
0101
|
|
Manufacturer Contact |
lisa
hernandez
|
60 middletown ave. |
north haven, CT 06473
|
2034925563
|
|
MDR Report Key | 8370097 |
MDR Text Key | 137144284 |
Report Number | 9612501-2019-00352 |
Device Sequence Number | 1 |
Product Code |
OCW
|
UDI-Device Identifier | 10884521100008 |
UDI-Public | 10884521100008 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K934738 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
02/26/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/30/2023 |
Device Model Number | 173016 |
Device Catalogue Number | 173016 |
Device Lot Number | J8F0592EX |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
01/31/2019
|
Initial Date FDA Received | 02/26/2019 |
Date Device Manufactured | 06/08/2018 |
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 |