Brand Name | ACESSA PROVU CONSOLE ASSEMBLY |
Type of Device | COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESORIES) |
Manufacturer (Section D) |
HOLOGIC, INC |
250 campus drive |
marlborough MA 01752 |
|
Manufacturer (Section G) |
HOLOGIC, INC. |
250 campus drive |
|
marlborough MA 01752 |
|
Manufacturer Contact |
ariel
lafuente
|
562 parkway |
coyol free zone building b24 |
san jose 20102
|
|
MDR Report Key | 15821371 |
MDR Text Key | 304957593 |
Report Number | 1222780-2022-00357 |
Device Sequence Number | 1 |
Product Code |
HFG
|
UDI-Device Identifier | 00854763006232 |
UDI-Public | (01)00854763006232(11)200814 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K181124 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
12/07/2022 |
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 Model Number | 7100 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
11/01/2022
|
Initial Date FDA Received | 11/17/2022 |
Supplement Dates Manufacturer Received | 11/01/2022
|
Supplement Dates FDA Received | 12/07/2022
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 08/14/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Sex | Female |