FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP MULTIPLE CLIP APPLIER
MDR report key: 249642
·
Received November 8, 1999
Report
- Report Number
- 1527736-1999-05728
- Event Type
- Malfunction
- Date Received
- November 8, 1999
- Report Date
- August 26, 1999
- Manufacturer
- LACEY MANUFACTURING CO.
- Product Code
- GDO
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT (2) DEVICES WERE USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE MCM20'S DO NOT FUNCTION. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE CASE. 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 | M4EE57 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |