FDA Adverse Event
Malfunction
Summary report: N
JAGTOME RX SPHINCTEROTOME
MDR report key: 1221504
·
Received November 5, 2008
Report
- Report Number
- 3005099803-2008-06025
- Event Type
- Malfunction
- Date Received
- November 5, 2008
- Date of Event
- October 8, 2008
- Report Date
- October 8, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- PMA / PMN Number
- K013153
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO THE COMPLAINT, THE SUSPECTED DEVICE IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.
Description of Event or Problem · 1
NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO MALFUNCTIONS THAT OCCURRED DURING THE PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2008-06024 FOR DETAILS REGARDING THE FIRST DEVICE. ACCORDING TO THE COMPLAINANT, THE DEVICE APPEARED TO BE STUCK IN THE BOWED STATE. THE DEVICE WAS NOT USED; THE PROCEDURE WAS COMPLETED WITH ANOTHER SPHINCTEROTOME DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JAGTOME RX SPHINCTEROTOME | KNS | BOSTON SCIENTIFIC CORPORATION | M00573540 | 12005146 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |