Brand Name | HARMONIC ACE CURVED SHEARS |
Type of Device | SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT |
Manufacturer (Section D) |
|
MDR Report Key | 8535829 |
MDR Text Key | 142738756 |
Report Number | MW5086018 |
Device Sequence Number | 1 |
Product Code |
NAY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
02/20/2019 |
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 Lot Number | M10170529 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 04/19/2019 |
Was Device Evaluated by Manufacturer? |
No Information
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 82 YR |
Patient Weight | 49 |
|
|