Brand Name | FLEX. INTUBATION VIDEO SCOPE 5.5 X 65 CM |
Type of Device | FLEX. INTUBATION VIDEO SCOPE |
Manufacturer (Section D) |
KARL STORZ ENDOVISION |
91 carpenter hill road |
charlton MA 01507 |
|
Manufacturer (Section G) |
KARL STORZ ENDOVISION |
91 carpenter hill road |
|
charlton MA 01507 |
|
Manufacturer Contact |
anja
fair
|
2151 e grand ave |
el segundo, CA 90245-5017
|
4242188738
|
|
MDR Report Key | 16336377 |
MDR Text Key | 309164551 |
Report Number | 1221826-2023-00025 |
Device Sequence Number | 1 |
Product Code |
CAL
|
UDI-Device Identifier | 04048551421598 |
UDI-Public | 04048551421598 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
05/03/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 11303BNXK |
Device Catalogue Number | 11303BNXK |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/10/2023
|
Initial Date FDA Received | 02/09/2023 |
Supplement Dates Manufacturer Received | 02/03/2023 02/03/2023 05/03/2023
|
Supplement Dates FDA Received | 02/14/2023 03/10/2023 05/03/2023
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/27/2022 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|