Brand Name | VERSA JET II EXACT HYDROSURGERY SYSTEM HANDPIECE |
Type of Device | LAVAGE, JET |
Manufacturer (Section D) |
|
MDR Report Key | 12828872 |
MDR Text Key | 280956021 |
Report Number | MW5105373 |
Device Sequence Number | 1 |
Product Code |
FQH
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/12/2021 |
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 | 08/10/2023 |
Device Model Number | 66800041 |
Device Lot Number | 50959076 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 11/16/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|