FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE** SKIN STAPLER 35 WIDE
MDR report key: 3122704
·
Received May 21, 2013
Report
- Report Number
- 3005075853-2013-02466
- Event Type
- Malfunction
- Date Received
- May 21, 2013
- Date of Event
- April 26, 2013
- Report Date
- April 30, 2013
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDT
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). THE ANALYSIS RESULTS CONFIRMED THAT THE INSTRUMENT WAS RECEIVED IN GOOD VISUAL CONDITION; THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY AND IT FIRED THE REMAINING 24 STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER BOX SHAPE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP GASTRECTOMY, THE STAPLES WERE MALFORMED WHEN THE DEVICE WAS USED ON THE STOMACH. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224695 | PROXIMATE** SKIN STAPLER 35 WIDE | REMOVABLE (SKIN) | GDT | ETHICON ENDO-SURGERY, LLC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |