FDA Adverse Event
Injury
Summary report: N
ENDOSTAT ELECTROSURGICAL UNIT
MDR report key: 786336
·
Received November 22, 2006
Report
- Report Number
- 1221941-2006-00001
- Event Type
- Injury
- Date Received
- November 22, 2006
- Report Date
- October 26, 2006
- Manufacturer
- MEDICAL SCIENTIFIC, INC.
- Product Code
- KNS
- PMA / PMN Number
- K913881
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
NOTE: EVENT DATE IS UNKNOWN. THE CUSTOMER HAS REPORTED A PT (AGE AND GENDER UNKNOWN) EXPERIENCED A SHOCK, WHILE USING A REFURBISHED ENDOSTAT 11 GENERATOR. PT CONDITION WAS NOT REPORTED TO BOSTON SCIENTIFIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOSTAT ELECTROSURGICAL UNIT | KNS | KNS | MEDICAL SCIENTIFIC, INC. | M0054080R0 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |