Brand Name | CAPTURA BIOPSY FORCEPS WITHOUT SPIKE |
Type of Device | PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT |
Manufacturer (Section D) |
COOK ENDOSCOPY |
4900 bethania station rd |
winston-salem NC 27105 |
|
Manufacturer (Section G) |
COOK ENDOSCOPY |
4900 bethania station rd |
|
winston-salem NC 27105 |
|
Manufacturer Contact |
scottie
fariole
|
4900 bethania station rd |
winston-salem, NC 27105
|
3367440157
|
|
MDR Report Key | 10597385 |
MDR Text Key | 208976405 |
Report Number | 1037905-2020-00414 |
Device Sequence Number | 1 |
Product Code |
PTS
|
UDI-Device Identifier | 00827002315761 |
UDI-Public | (01)00827002315761(17)230601(10)W4351343 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
09/28/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/28/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/01/2023 |
Device Model Number | G31576 |
Device Catalogue Number | DBF-2.4-230-S |
Device Lot Number | W4351343 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 09/01/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/01/2020 |
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 |