Brand Name | ENDOFLATOR 50, W/INTEGRATED SCB MODULE |
Type of Device | LAPAROSCOPIC GAS DISTENSION SYSTEM |
Manufacturer (Section D) |
KARL STORZ SE & CO. KG |
dr.-karl-storz-strasse 34 |
tuttlingen 78532 |
GM 78532 |
|
Manufacturer (Section G) |
KARL STORZ SE & CO. KG |
dr.-karl-storz-strasse 34 |
|
tuttlingen 78532 |
GM
78532
|
|
Manufacturer Contact |
anja
fair
|
2151 e grand ave |
el segundo, CA 90245
|
4242188247
|
|
MDR Report Key | 18070244 |
MDR Text Key | 327376884 |
Report Number | 9610617-2023-00362 |
Device Sequence Number | 1 |
Product Code |
FCX
|
UDI-Device Identifier | 04048551326657 |
UDI-Public | 4048551326657 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K161554 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
11/03/2023 |
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 | UI500 |
Device Catalogue Number | UI500 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/17/2020
|
Initial Date FDA Received | 11/04/2023 |
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 |
Patient Sex | Male |
Patient Weight | 112 KG |