FDA Adverse Event
Malfunction
Summary report: N
ENDOSTAT II ELECTROSURGICAL UNI
MDR report key: 1155808
·
Received September 3, 2008
Report
- Report Number
- 3005099803-2008-04290
- Event Type
- Malfunction
- Date Received
- September 3, 2008
- Date of Event
- August 4, 2008
- Report Date
- August 6, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- PMA / PMN Number
- K913881
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED. THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE 2008 15-MONTH HEMOSTASIS GENERATOR PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.
Description of Event or Problem · 1
IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTRO-SURGICAL GENERATOR WAS BEING TESTED BY THE HOSPITAL'S BIOMED DEPARTMENT TWO DAYS PRIOR. ACCORDING TO THE COMPLAINANT, "THERE IS NO OUTPUT WHEN ABLATING."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOSTAT II ELECTROSURGICAL UNI | KNS | BOSTON SCIENTIFIC CORPORATION | M0054080R0 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |