Brand Name | TELESCOPE "OES ELITE", 4 MM, 12°, HD, AUTOCLAVABLE |
Type of Device | TELESCOPE, RIGID, ENDOSCOPIC |
Manufacturer (Section D) |
OLYMPUS WINTER & IBE GMBH |
kuehnstrasse 61 |
hamburg, hamburg 22045 |
GM 22045 |
|
Manufacturer (Section G) |
OLYMPUS WINTER & IBE GMBH |
kuehnstrasse 61 |
|
hamburg, hamburg |
|
Manufacturer Contact |
todd
brill
|
800 west park drive |
westborough, MA 01581
|
5082077661
|
|
MDR Report Key | 16897240 |
MDR Text Key | 314853618 |
Report Number | 9610773-2023-01261 |
Device Sequence Number | 1 |
Product Code |
FGC
|
UDI-Device Identifier | 04042761077507 |
UDI-Public | 04042761077507 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K151191 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
07/21/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/09/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | WA2T412A |
Device Catalogue Number | WA2T412A |
Device Lot Number | 807152 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/12/2023 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 07/04/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/21/2021 |
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 |
|
|