Brand Name | THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP |
Type of Device | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) |
Manufacturer (Section D) |
OLYMPUS MEDICAL SYSTEMS CORP. |
2400 ringwood ave. |
san jose CA 95131 |
|
MDR Report Key | 8850664 |
MDR Text Key | 152943227 |
Report Number | 8850664 |
Device Sequence Number | 1 |
Product Code |
KNS
|
UDI-Device Identifier | 04953170337574 |
UDI-Public | (01)04953170337574(17)220311(10)KR846642 |
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 |
07/02/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/01/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | TB-0535FC |
Device Lot Number | KR846642 |
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 | 07/02/2019 |
Event Location |
Hospital
|
Date Report to Manufacturer | 08/01/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 19710 DA |
Patient Weight | 84 |
|
|