Brand Name | C4140, 5MMX45CM EPIX LAPA GRASPER, 10/BX |
Type of Device | LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC |
Manufacturer (Section D) |
APPLIED MEDICAL RESOURCES |
22872 avenida empresa |
rancho santa margarita CA 92688 |
|
Manufacturer Contact |
wendy
kobayashi
|
22872 avenida empresa |
rancho santa margarita, CA 92688
|
9497138059
|
|
MDR Report Key | 10204119 |
MDR Text Key | 196796320 |
Report Number | 2027111-2020-00489 |
Device Sequence Number | 1 |
Product Code |
NWV
|
UDI-Device Identifier | 00607915110154 |
UDI-Public | (01)00607915110154(17)220602(30)01(10)1357491 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
06/26/2020 |
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 | 06/02/2022 |
Device Model Number | C4140 |
Device Catalogue Number | 100915402 |
Device Lot Number | 1357491 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/26/2020 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/10/2020
|
Initial Date FDA Received | 06/26/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/03/2019 |
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 |