Brand Name | LIGACLIP |
Type of Device | APPLIER, SURGICAL, CLIP |
Manufacturer (Section D) |
ETHICON ENDO-SURGERY, LLC |
475 calle c |
guaynabo PR 00969 |
|
MDR Report Key | 15427233 |
MDR Text Key | 299955659 |
Report Number | 15427233 |
Device Sequence Number | 1 |
Product Code |
GDO
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
08/12/2022 |
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 | MCS20 |
Device Catalogue Number | MCS20 |
Device Lot Number | 857A92 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 08/12/2022 |
Event Location |
Hospital
|
Date Report to Manufacturer | 09/15/2022 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 09/15/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 9125 DA |
Patient Sex | Male |
|
|