FDA Adverse Event
Malfunction
Summary report: N
ECHELON 45 ENDOPATH STAPLER
MDR report key: 2133451
·
Received June 20, 2011
Report
- Report Number
- 3005075853-2011-02470
- Event Type
- Malfunction
- Date Received
- June 20, 2011
- Date of Event
- May 25, 2011
- Report Date
- May 24, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K051002
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Additional Manufacturer Narrative · 1
(B)(4). UPON REVIEW OF ADDITIONAL INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT, AND IS BEING CONSIDERED NOT REPORTABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, THE SURGEON COULD NOT OPEN THE JAW AFTER THE CARTRIDGE WAS RELOADED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THIS DEVICE, THE PROCEDURE WAS PROLONGED 15 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHELON 45 ENDOPATH STAPLER | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | UNK | H43F6L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |