FDA Adverse Event
Malfunction
Summary report: N
ENDOSTAT II ELECTROSURGICAL UNIT
MDR report key: 1467904
·
Received June 3, 2009
Report
- Report Number
- 3005099803-2009-02687
- Event Type
- Malfunction
- Date Received
- June 3, 2009
- Date of Event
- April 30, 2009
- Report Date
- May 6, 2009
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- PMA / PMN Number
- K913881
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2009. ("50+" YEAR OLD). ACCORDING TO THE COMPLAINANT, WHILE TESTING THE UNIT, THE BIPOLAR WOULD NOT HEAT. THE SITE WAS ABLE TO MOVE CABLES AROUND AND RECEIVE POWER FROM THE UNIT. THE PROCEDURE WAS COMPLETED WITH THE SAME ENDOSTAT II ELECTROSURGICAL UNIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOSTAT II ELECTROSURGICAL UNIT | KNS | BOSTON SCIENTIFIC CORPORATION | M0054080R0 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |