Brand Name | RENEW MINI ENDOCUT SCISSOR TIP, DISPOSABLE |
Type of Device | MANUAL DETACHABLE SURGICAL INSTRUMENT |
Manufacturer (Section D) |
MICROLINE SURGICAL |
50 dunham rd suite 1500 |
beverly MA 01915 |
|
Manufacturer (Section G) |
MICROLINE SURGICAL |
50 dunham rd suite 1500 |
|
beverly MA 01915 |
|
Manufacturer Contact |
scott
marchand davis
|
50 dunham rd suite 1500 |
beverly, MA 01915
|
9789229810
|
|
MDR Report Key | 15991792 |
MDR Text Key | 308384040 |
Report Number | 1223422-2022-00010 |
Device Sequence Number | 1 |
Product Code |
GEI
|
UDI-Device Identifier | 00811099010012 |
UDI-Public | 00811099010012 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K962119 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
12/15/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/15/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 3152 |
Device Catalogue Number | 3152 |
Device Lot Number | 00160138 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/05/2022 |
Date Manufacturer Received | 11/22/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/14/2022 |
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 |