Brand Name | HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°, STERILE, SINGLE USE |
Type of Device | HF-RESECTION ELECTRODES |
Manufacturer (Section D) |
OLYMPUS WINTER & IBE GMBH |
kuehnstrasse 61 |
hamburg |
|
MDR Report Key | 8394083 |
MDR Text Key | 137936975 |
Report Number | 9610773-2019-00052 |
Device Sequence Number | 1 |
Product Code |
FAS
|
UDI-Device Identifier | 14042761080177 |
UDI-Public | 14042761080177 |
Combination Product (y/n) | N |
PMA/PMN Number | K100275 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Type of Report
| Initial,Followup |
Report Date |
04/25/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/06/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 08/01/2023 |
Device Model Number | WA22302D |
Device Catalogue Number | WA22302D |
Device Lot Number | 1000031640 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/03/2019 |
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 04/17/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | OLYMPUS HF CABLE, BIPOLAR, 4 M (WA00014A); OLYMPUS HF-CABLE, 4 M (WA00013A); OLYMPUS WORKING ELEMENT, ACTIVE (WA22366A); OLYMPUS HF CABLE, BIPOLAR, 4 M (WA00014A); OLYMPUS HF-CABLE, 4 M (WA00013A); OLYMPUS WORKING ELEMENT, ACTIVE (WA22366A) |
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