FDA Adverse Event
Malfunction
Summary report: N
ENDOSTAT II ELECTROSURGICAL UNIT
MDR report key: 1180831
·
Received September 23, 2008
Report
- Report Number
- 3005099803-2008-04785
- Event Type
- Malfunction
- Date Received
- September 23, 2008
- Date of Event
- August 25, 2008
- Report Date
- August 26, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- PMA / PMN Number
- K913881
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNK, AND THE EXPIRATION DATE CANNOT BE DETERMINED. THE DEVICE HAS NOT BEEN RETURNED. THE DEVICE EVALUATION HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT AN ENDOSTAT II ELECTROSURGICAL UNIT WAS USED DURING AN ELECTROCAUTERY PROCEDURE PERFORMED IN 2008. ACCORDING TO THE COMPLAINANT, THERE WAS NO OUTPUT POWER IN THE BI-POLAR MODE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOSTAT II ELECTROSURGICAL UNIT. NO INFO WAS AVAILABLE REGARDING THE PT'S CONDITION FOLLOWING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOSTAT II ELECTROSURGICAL UNIT | KNS | BOSTON SCIENTIFIC CORPORATION | M0054080R0 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |