FDA Adverse Event
Injury
Summary report: N
RESOLUTION CLIP DEVICE
MDR report key: 1324247
·
Received February 20, 2009
Report
- Report Number
- 3005099803-2009-00682
- Event Type
- Injury
- Date Received
- February 20, 2009
- Date of Event
- January 16, 2009
- Report Date
- January 21, 2009
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MND
- PMA / PMN Number
- K040148
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
BOSTON SCIENTIFIC CORPORATION WAS INFORMED THAT DURING A COLONOSCOPY PROCEDURE, THE CLIP WAS EXTRUDED FROM SHEATH INSIDE PT AND LINED UP WITH POLYPECTOMY SITE. UPON ATTEMPTING TO CLOSE THE CLIP, IT WOULD NOT CLOSE BECAUSE IT OPENED TOO WIDE OR WAS IN THE WRONG POSITION. IT THEN FELL OFF THE APPLICATOR, AND HAD TO BE PULLED OUT OF THE COLON WITH FORCEPS. THERE WAS NO PATIENT INJURIES OR COMPLICATIONS INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESOLUTION CLIP DEVICE | MND | BOSTON SCIENTIFIC CORPORATION | M00522611 | 0ML8092609 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |