Brand Name | AEM FIXED TIP ELECTRODE, 5MM REUSABLE - J-HOOK |
Type of Device | LAPAROSCOPIC ELECTROSURGICAL DEVICE |
Baseline Device 510(K) Number | |
Baseline Device PMA Number | |
Manufacturer (Section F) |
ENCISION, INC. |
4828 sterling dr. |
boulder CO 80301 |
|
Manufacturer (Section D) |
ENCISION, INC. |
4828 sterling dr. |
boulder CO 80301 |
|
Manufacturer Contact |
judith
king
|
4828 sterling dr. |
boulder
, CO 80301 |
(303)
440
-9250
ext 117
|
|
Device Event Key | 342709 |
MDR Report Key | 353473 |
Event Key | 333035 |
Report Number | 1722040-2001-00010 |
Device Sequence Number | 1 |
Product Code | GEI |
Report Source |
Manufacturer
|
Source Type |
Distributor
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
09/21/2001 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 09/24/2001 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device MODEL Number | ES3510B |
Device Catalogue Number | ES3510B |
Device LOT Number | GB |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 09/08/2001 |
Is The Reporter A Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 09/05/2001 |
Was Device Evaluated By Manufacturer? |
No
|
Date Device Manufactured | 02/01/2001 |
Is The Device Single Use? |
No
|
Is the Device an Implant? |
No
|
Is this an Explanted Device? |
|
Type of Device Usage |
Unkown
|