FDA Adverse Event
Malfunction
Summary report: N
VISISTAT 35W
MDR report key: 2062528
·
Received March 21, 2011
Report
- Report Number
- 3003898360-2011-00115
- Event Type
- Malfunction
- Date Received
- March 21, 2011
- Report Date
- February 25, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- GDT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER SO INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE STAPLER JAMMED. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISISTAT 35W | VISISTAT SKIN STAPLER | GDT | TELEFLEX MEDICAL | NA | 01K1000047 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |