FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR
MDR report key: 728484
·
Received June 19, 2006
Report
- Report Number
- 1527736-2006-02752
- Event Type
- Malfunction
- Date Received
- June 19, 2006
- Date of Event
- April 4, 2006
- Report Date
- April 7, 2006
- Manufacturer
- ETHICON ENDO SURGERY, INC. (CINCINNATI)
- Product Code
- GCJ
- PMA / PMN Number
- k020779
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE ANALYSIS SHOWED THAT THE DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AND WITH A CARTRIDGE LOADED IN THE DEVICE. THE CARTRIDGE WAS RECEIVED PARTIALLY FIRED AND WITH NO DAMAGE TO THE CARTRIDGE LOCK OUT TAB. THE RETURNED DEVICE WAS FOUND TO BE NON FUNCTIONAL AS THE FIRING MECHANISM WAS NOTED TO BE DAMAGED. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH WERE FOUND DAMAGED. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. 510(K) NUMBER IS K020779.
Description of Event or Problem · 1
DURING AN UNK PROCEDURE, IT WAS IMPOSSIBLE TO SQUEEZE THE HANDLES, THE DEVICE JAMMED AT THE FIRST FIRING. SURGEON USED ANOTHER LIKE DEVICE TO COMPLETE THE CASE. NO PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR | GDW | GCJ | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | C4DJ6Y |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |