FDA Adverse Event
Malfunction
Summary report: N
75MM SELECTABLE NEW TLC
MDR report key: 2133376
·
Received June 20, 2011
Report
- Report Number
- 3005075853-2011-02466
- Event Type
- Malfunction
- Date Received
- June 20, 2011
- Date of Event
- May 26, 2011
- Report Date
- June 9, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K092577
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A OESOPHAGECTOMY AND PARTIAL GASTRECTOMY PROCEDURE, WHILE USING DEVICE TO CUT ACROSS STOMACH, A GOLD CARTRIDGE WAS SELECTED AND THE DEVICE FELT STICKY TO CLOSE AND THEN DIFFICULT TO FIRE. THE RESULT WAS MALFORMED STAPLES AT THE DISTAL END OF STAPLE LINE; THIS WAS FIRST FIRING. 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 | 75MM SELECTABLE NEW TLC | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | NA | G4U481 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | RELOAD-SR75 |