Brand Name | ACUSNARE POLYPECTOMY SNARE |
Type of Device | KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) |
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 | 8084085 |
MDR Text Key | 128416736 |
Report Number | 1037905-2018-00537 |
Device Sequence Number | 1 |
Product Code |
KNS
|
UDI-Device Identifier | 00827002226319 |
UDI-Public | (01)00827002226319(17)210705(10)W4089755 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K851958 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
10/25/2018 |
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 | 07/05/2021 |
Device Catalogue Number | ASM-1-S |
Device Lot Number | W4089755 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/02/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/25/2018 |
Initial Date FDA Received | 11/19/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/05/2018 |
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 |