Brand Name | DEFLECTOR , CATHETER |
Type of Device | DEFLECTING MECHANISM WITH 2 INSTRUMENT CHANNELS |
Manufacturer (Section D) |
KARL STORZ SE & CO. KG |
dr.-karl-storz-strasse 34 |
78532 |
tuttlingen, gm, |
|
MDR Report Key | 9176615 |
MDR Text Key | 194174185 |
Report Number | 9610617-2019-00097 |
Device Sequence Number | 1 |
Product Code |
ODB
|
UDI-Device Identifier | 04048551231876 |
UDI-Public | 4048551231876 |
Combination Product (y/n) | N |
PMA/PMN Number | K943697 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Type of Report
| Initial,Followup |
Report Date |
10/10/2019 |
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 | 27026EF |
Device Catalogue Number | 27026EF |
Device Lot Number | WU |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
09/16/2019 |
Initial Date FDA Received | 10/10/2019 |
Supplement Dates Manufacturer Received | 09/16/2019
|
Supplement Dates FDA Received | 11/04/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 76 YR |
Patient Weight | 109 |
|
|