FDA Adverse Event
Malfunction
Summary report: N
D-CLIP STANDARD/MINI APPLIER/REMOVER
MDR report key: 19094762
·
Received April 12, 2024
Report
- Report Number
- 8010890-2024-00002
- Event Type
- Malfunction
- Date Received
- April 12, 2024
- Date of Event
- February 19, 2024
- Report Date
- March 21, 2024
- Manufacturer
- PETER LAZIC GMBH MICROSURGICAL INNOVATIONS
- Product Code
- HCI
- UDI-DI
- 04250603739630
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE CASE IS CURRENTLY BEING INVESTIGATED.
Description of Event or Problem · 0
OUR CUSTOMER HAS INFORMED US THAT THE APPLIER REMAINS JAMMED. THE APPLIER DOES NOT RELEASE CLIPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1508400 | D-CLIP STANDARD/MINI APPLIER/REMOVER | APPLIER, ANEURYSM CLIP | HCI | PETER LAZIC GMBH MICROSURGICAL INNOVATIONS | 35.421 | X591938 | 04250603739630 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |