Brand Name | TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE |
Type of Device | LAPAROSCOPE |
Manufacturer (Section D) |
OLYMPUS WINTER & IBE GMBH |
kuehnstrasse 61 |
hamburg, deutschland 22045 |
GM 22045 |
|
Manufacturer (Section G) |
OLYMPUS WINTER & IBE GMBH |
kuehnstrasse 61 |
|
hamburg, deutschland |
|
Manufacturer Contact |
todd
brill
|
800 west park drive |
westborough, MA 01581
|
5082077661
|
|
MDR Report Key | 17762376 |
MDR Text Key | 323605290 |
Report Number | 9610773-2023-02600 |
Device Sequence Number | 1 |
Product Code |
EWY
|
UDI-Device Identifier | 04042761052764 |
UDI-Public | 04042761052764 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K950076 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
01/02/2024 |
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 | WA53005A |
Device Lot Number | 797332 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/24/2023 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
08/21/2023
|
Initial Date FDA Received | 09/17/2023 |
Supplement Dates Manufacturer Received | 12/29/2023
|
Supplement Dates FDA Received | 01/02/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/21/2019 |
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 |
Treatment | OTV-S190 |
|
|