FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP MULTIPLE CLIP APPLIER
MDR report key: 250510
·
Received November 16, 1999
Report
- Report Number
- 1527736-1999-05891
- Event Type
- Malfunction
- Date Received
- November 16, 1999
- Date of Event
- October 21, 1999
- Report Date
- October 21, 1999
- Manufacturer
- LACEY MANUFACTURING CO.
- Product Code
- GDO
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE AFFILIATE THAT THE (1) MCM30 WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE CLIPS WOULD NOT FEED. THE CASE WAS COMPLETED WITH ANOTHER INSTRUMENT AND THERE WAS NO CONSEQUENCE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGACLIP MULTIPLE CLIP APPLIER | CLIP APPLIER | GDO | LACEY MANUFACTURING CO. | NA | M4FF29 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |