FDA Adverse Event
Malfunction
Summary report: N
ONEPORT 5-11MM TROCAR W/CONICAL DILATING TIP
MDR report key: 1619169
·
Received February 24, 2010
Report
- Report Number
- 1320894-2010-00019
- Event Type
- Malfunction
- Date Received
- February 24, 2010
- Date of Event
- November 16, 2009
- Report Date
- February 23, 2010
- Manufacturer
- CONMED CORP.
- Product Code
- FBM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN THE QUALITY ENGINEER HAS COMPLETED THE INVESTIGATION, WE WILL FILE A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED BY FACILITY THAT "CLEAR PLASTIC PART OF THE SEAL BROKE AND FELL INTO PATIENT WHILE INSERTING, THE JAWS OF CLIP APPLIER WAS CATCHING ONTO THE SEAL".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONEPORT 5-11MM TROCAR W/CONICAL DILATING TIP | DILATING TROCAR W/RIBBED CANNULA | FBM | CONMED CORP. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |