Brand Name | THUNDERBEAT 5 MM,35 CM,FRONT-ACTUATED GRIP TYPE S |
Type of Device | INSTRUMENT, ULTRASONIC SURGICAL |
Manufacturer (Section D) |
OLYMPUS MEDICAL SYSTEMS CORP. |
800 west park drive |
westborough MA 01581 |
|
MDR Report Key | 15665620 |
MDR Text Key | 302343710 |
Report Number | 15665620 |
Device Sequence Number | 1 |
Product Code |
LFL
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
10/03/2022 |
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 Model Number | TB-0535FCS |
Device Catalogue Number | TB0535FCS |
Device Lot Number | KR239760 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 10/03/2022 |
Event Location |
Hospital
|
Date Report to Manufacturer | 10/24/2022 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 10/25/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Sex | Female |
|
|