Brand Name | FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE |
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 | 9769165 |
MDR Text Key | 224676176 |
Report Number | 1037905-2020-00108 |
Device Sequence Number | 1 |
Product Code |
KNS
|
Combination Product (y/n) | N |
Reporter Country Code | DA |
PMA/PMN Number | K052051 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
02/04/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/28/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | FS-OMNI-ACRO-35-205 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/04/2020 |
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 |