Brand Name | ENDO GIA ULTRA UNIVERSAL |
Type of Device | STAPLE, IMPLANTABLE |
Manufacturer (Section D) |
COVIDIEN |
15 hampshire street |
mansfield MA 02048 |
|
MDR Report Key | 6085219 |
MDR Text Key | 59361140 |
Report Number | 6085219 |
Device Sequence Number | 1 |
Product Code |
GAG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/02/2016 |
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 |
No Information
|
Device Lot Number | P6F0309X/N6H0173UX |
Other Device ID Number | 60MM RELOAD |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 11/02/2016 |
Event Location |
Hospital
|
Date Report to Manufacturer | 11/02/2016 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 11/08/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 24 YR |
|
|