Brand Name | INNER SHEATH, FOR 26 FR. OUTER SHEATH |
Type of Device | RIGID ENDOSCOPE 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, hamburg 22045 |
GM
22045
|
|
Manufacturer Contact |
todd
brill
|
800 west park drive |
westborough, MA 01581
|
5082077661
|
|
MDR Report Key | 19110997 |
MDR Text Key | 340907417 |
Report Number | 9610773-2024-01023 |
Device Sequence Number | 1 |
Product Code |
HIH
|
UDI-Device Identifier | 04042761029339 |
UDI-Public | 04042761029339 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K931995 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
04/15/2024 |
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 |
Other
|
Device Model Number | A22040A |
Device Lot Number | 096W-0007 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/03/2024 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/09/2024
|
Initial Date FDA Received | 04/15/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 06/11/2009 |
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 |