Brand Name | RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS |
Type of Device | RESECTOSCOPE SHEATH |
Manufacturer (Section D) |
OLYMPUS WINTER & IBE GMBH |
kuehnstrasse 61 |
hamburg, hamburg 22045 |
GM 22045 |
|
Manufacturer (Section G) |
OLYMPUS WINTER & IBE GMBH |
kuehnstrasse 61 |
|
hamburg 22045 |
GM
22045
|
|
Manufacturer Contact |
todd
brill
|
800 west park drive |
westborough, MA 01581
|
5082077661
|
|
MDR Report Key | 18184286 |
MDR Text Key | 328976894 |
Report Number | 9610773-2023-03369 |
Device Sequence Number | 1 |
Product Code |
HIH
|
UDI-Device Identifier | 04042761023658 |
UDI-Public | 04042761023658 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K931995 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/21/2023 |
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 | A42011A |
Device Lot Number | 21419 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/15/2023 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
11/12/2023
|
Initial Date FDA Received | 11/21/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/29/2021 |
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 |
Treatment | WORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE. |
|
|