FDA Adverse Event
Injury
Summary report: N
BLADELESS VP 5MM ST W/ FIXATION
MDR report key: 1515485
·
Received October 21, 2009
Report
- Report Number
- 1219930-2009-00708
- Event Type
- Injury
- Date Received
- October 21, 2009
- Date of Event
- September 25, 2009
- Report Date
- September 25, 2009
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GCJ
- PMA / PMN Number
- K081169
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE INITIAL REPORT SENT: 10/21/2009.
Description of Event or Problem · 1
PROCEDURE TYPE: LAP CHOLE. PATIENT GENDER: UNK. ACCORDING TO THE REPORTER: THE BLUE PART OF THE OBTURATOR TIP BROKE OFF INTO THE PATIENT'S ABDOMINAL WALL. IT COULD NOT BE REPORTED IF THE PIECE WAS REMOVED. THE OPERATING TIME AND INCISION WERE NOT EXTENDED AS A RESULT. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BLADELESS VP 5MM ST W/ FIXATION | DISPOSABLE SURGICAL ACCESS DEVICE | GCJ | NORTH HAVEN - USS | N9G0840UM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |