FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR
MDR report key: 726477
·
Received June 13, 2006
Report
- Report Number
- 1527736-2006-02688
- Event Type
- Malfunction
- Date Received
- June 13, 2006
- Date of Event
- March 7, 2006
- Report Date
- March 9, 2006
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (CINCINNATI)
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE DEVICE WAS RECIEVED IN GOOD VISUAL CONDITION AND WITH A CARTRIDGE LOADED IN THE DEVICE. THE CARTRIDGE WAS RECIEVED PARTIALLY FIRED AND WITH NO DAMAGE TO THE CARTRIDGE LOCK OUT TAB. WHEN TESTED FOR FUNCTIONALITY THE RETURNED DEVICE ONLY PARTIALLY FIRED AS THE FIRING MECHANISM WAS NOTED TO BE DAMAGED. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE LEFT SHROUD PINION AXLE SUPPORT WAS FOUND DAMAGED. CARTRIDGE BATCH# A5C87U (510(K)#K020779)
Description of Event or Problem · 1
DURING A LAPAROSCOPIC SPLENECTOMY PROCEDURE, THE DEVICE STOPPED FIRING PROPERLY AND APPEARED JAMMED. STAPLER WAS REMOVED. ANOTHER STAPLER WAS OPENED AND THE CASE WAS PROCEEDED. NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR | GDW | GDW | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | A4CA02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |