Brand Name | INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE |
Type of Device | PKL, LIGATOR, HEMORRHOIDAL |
Manufacturer (Section D) |
WILSON-COOK MEDICAL INC |
4900 bethania station rd |
winston-salem NC 27105 |
|
Manufacturer (Section G) |
COOK ENDOSCOPY |
4900 bethania station rd |
|
winston-salem NC 27105 |
|
Manufacturer Contact |
sabrina
o'brien
|
4900 bethania station rd |
winston-salem, NC 27105
|
3367440157
|
|
MDR Report Key | 14787512 |
MDR Text Key | 295054085 |
Report Number | 1037905-2022-00309 |
Device Sequence Number | 1 |
Product Code |
PKL
|
UDI-Device Identifier | 00827002580107 |
UDI-Public | (01)00827002580107(17)250301(10)W4570173 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
06/23/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/23/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | G58010 |
Device Catalogue Number | INSC-P-7-230-S |
Device Lot Number | W4570173 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 06/02/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/01/2022 |
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;
|
Patient Sex | Male |