FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 3.5MM
MDR report key: 729180
·
Received June 16, 2006
Report
- Report Number
- 1527736-2006-02751
- Event Type
- Malfunction
- Date Received
- June 16, 2006
- Date of Event
- May 1, 2006
- Report Date
- June 15, 2006
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- KOG
- PMA / PMN Number
- k020779
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
H6:DAMAGED FIRING AND CLOSING MECHANIS. THE ANALYSIS SHOWED THAT THE DEVICE WAS RECEIVED WITH THE FIRING AND CLOSING MECHANISM DAMAGED AND WITH A CARTRIDGE LOADED IN THE DEVICE . THE CARTRIDGE WAS RECEIVED FULLY LOADED WITH STAPLES . THE RETURNED DEVCIE WAS FOUND TO BE NON-FUNCTIONAL. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS. THE FIRING TRIGGER TEETH AND THE YOKE TEETH WERE FOUND BROKEN. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. 510K#: K020779
Description of Event or Problem · 1
DURING A THORACOSCOPIC WEDGE RESECTION THE DEVICE FELT STRANGE WHEN CLOSING. THE DEVICE WAS NOT USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 3.5MM | GDW | KOG | ETHICON ENDO-SURGERY, INC. | NA | C4D67T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |