Brand Name | SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM |
Type of Device | POWERED LASER SURGICAL INSTRUMENT |
Manufacturer (Section D) |
GYRUS ACMI, INC. |
800 west park drive |
westborough MA 01581 |
|
Manufacturer (Section G) |
GYRUS ACMI, INC. |
800 west park drive |
|
westborough MA 01581 |
|
Manufacturer Contact |
todd
brill
|
800 west park drive |
westborough, MA 01581
|
5082077661
|
|
MDR Report Key | 18570309 |
MDR Text Key | 333558495 |
Report Number | 3003790304-2024-00013 |
Device Sequence Number | 1 |
Product Code |
GEX
|
UDI-Device Identifier | 00821925044111 |
UDI-Public | 00821925044111 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K183647 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
01/24/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/24/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | TFL-PLS |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 01/04/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Age | 70 YR |
Patient Sex | Male |
Patient Ethnicity | Non Hispanic |
Patient Race | White |