FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE** SKIN STAPLER 35 WIDE
MDR report key: 2012667
·
Received March 10, 2011
Report
- Report Number
- 3005075853-2011-00952
- Event Type
- Malfunction
- Date Received
- March 10, 2011
- Report Date
- February 16, 2011
- 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
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE ANALYSIS RESULTS SHOWED THAT THE DEVICE WAS RECEIVED WITH DRY BODY FLUIDS IN THE MAGAZINE. THE DEVICE WAS CLEANED AND THE TESTED FOR FUNCTIONALITY. THE DEVICE CYCLED, FED AND FORMED THE REMAINING STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER BOX SHAPE. NO BATCH RECORD REVIEW COULD BE PERFORMED AS NO LOT NUMBER WAS PROVIDED.
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE FIRED MALFORMED STAPLES. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE** SKIN STAPLER 35 WIDE | SKIN STAPLER | GDT | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |