Brand Name | VERSAPORT V2 BLADELESS OPT 12 |
Type of Device | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
Manufacturer (Section D) |
COVIDIEN, FORMERLY US SURGICAL A DIVISON |
60 middletown ave |
north haven CT 06473 |
|
Manufacturer (Section G) |
COVIDIEN, FORMERLY US SURGICAL A DIVISON |
60 middletown ave |
|
north haven CT 06473 |
|
Manufacturer Contact |
sharon
murphy
|
60 middletown ave |
north haven, CT 06473
|
2034925267
|
|
MDR Report Key | 5942345 |
MDR Text Key | 54399160 |
Report Number | 1219930-2016-00953 |
Device Sequence Number | 1 |
Product Code |
GCJ
|
Combination Product (y/n) | N |
Reporter Country Code | BR |
PMA/PMN Number | K130435 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
08/17/2016 |
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 | 09/30/2020 |
Device Model Number | ONB12STF |
Device Catalogue Number | ONB12STF |
Device Lot Number | N5J0662X |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
08/17/2016 |
Initial Date FDA Received | 09/12/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 01/22/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|