FDA Adverse Event
Malfunction
Summary report: N
ETS*45 ENDO LIN CUT
MDR report key: 1993544
·
Received February 16, 2011
Report
- Report Number
- 3005075853-2011-00657
- Event Type
- Malfunction
- Date Received
- February 16, 2011
- Date of Event
- August 6, 2010
- Report Date
- January 27, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.
Additional Manufacturer Narrative · 1
(B)(4). NO DEVICE RETURNED THE ANALYSIS RESULTS FOUND THAT ONE (B)(4) RELOAD WAS RECEIVED IN GOOD VISUAL CONDITION AND FULLY FIRED. NO FUNCTIONAL TEST WAS PERFORMED DUE TO THE CONDITION OF THE RELOAD. EVENT COULD NOT BE CONFIRMED AS NO INSTRUMENT WAS RECEIVED FOR ANALYSIS.
Additional Manufacturer Narrative · 1
(B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A TOTAL COLECTOMY PROCEDURE, THE DEVICE DID NOT FIRE. TWO RELOADS STAPLED BUT DID NOT CUT AND STAPLED ONLY ONE SIDE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETS*45 ENDO LIN CUT | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | UNK | G4TN0Z |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |