FDA Adverse Event
Malfunction
Summary report: N
ESOPHYX2 -04
MDR report key: 1881004
·
Received October 6, 2010
Report
- Report Number
- 3005473391-2010-00020
- Event Type
- Malfunction
- Date Received
- October 6, 2010
- Date of Event
- August 12, 2009
- Report Date
- October 5, 2010
- Manufacturer
- REDMOND
- Product Code
- ODE
- PMA / PMN Number
- K092400
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FINDINGS: THE SERVICE LOOP DISCONNECTED FROM THE TISSUE MOLD ELBOW DUE TO A MFG PROCESS ISSUE. (B)(4), RELEASED ON (B)(4) 2009, VALIDATED A CHANGE TO THE BONDING PROCESS WHICH INCREASED THE PROCESS CAPABILITY CPK FROM 1.0 TO 1.78. THIS MALFUNCTION REPORT IS NOW BEING REPORTED AFTER WRITTEN FEEDBACK FROM CDRH REGARDING THIS FAILURE TYPE.
Description of Event or Problem · 1
THE COMPANY REP REPORTED THAT THE SERVICE LOOP DISCONNECTED FROM THE TISSUE MOLD, DANGLING THE HELICAL RETRACTOR. AFTER MANIPULATING THE DEVICE IT WAS REMOVED WITH NO ADVERSE AFFECT TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ESOPHYX2 -04 | ODE | REDMOND | R2000 | 400326 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR |