FDA Adverse Event
Malfunction
Summary report: N
CONMED TROGARD SYSTEM
MDR report key: 1052838
·
Received May 27, 2008
Report
- Report Number
- 1320894-2008-00071
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- May 5, 2008
- Report Date
- May 27, 2008
- Manufacturer
- CONMED CORPORATION
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN I RECEIVE THAT INVESTIGATION REPORT, I WILL FILE A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT "PIECE OF THE TIP OF THE CANNULA BROKE OFF AND FELL IN PT. PIECE WAS NOT RETRIEVED. PIECE COULD STILL BE IN THE ABDOMEN."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONMED TROGARD SYSTEM | TROCAR CANNULA & OBTURATOR | GCJ | CONMED CORPORATION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |