FDA Adverse Event
Malfunction
Summary report: N
RESOLUTION CLIP DEVICE
MDR report key: 1202104
·
Received October 16, 2008
Report
- Report Number
- 3005099803-2008-05322
- Event Type
- Malfunction
- Date Received
- October 16, 2008
- Date of Event
- September 10, 2008
- Report Date
- September 16, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MND
- PMA / PMN Number
- K040148
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER OF THE SUSPECT DEVICE IS UNKNOWN; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES CAN NOT BE DETERMINED. THE SUSPECT DEVICE HAS BEEN DISPOSED. A DEVICE EVALUATION WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.
Description of Event or Problem · 1
IN 2008, BOSTON SCIENTIFIC CORPORATION WAS INFORMED THAT DURING AN UPPER ENDOSCOPY, WHEN THE PHYSICIAN WENT TO DEPLOY THE RESOLUTION CLIP DEVICE, THE CLIP DETACHED FROM THE SHEATH ON ITS OWN INSIDE THE PATIENT. THE CLIP WAS NOT RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT PATIENT COMPLICATIONS. PATIENT IS "FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESOLUTION CLIP DEVICE | MND | BOSTON SCIENTIFIC CORPORATION | M00522610 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |