FDA Adverse Event
Malfunction
Summary report: N
SPACEMAKER BLUNT TIP TROCAR 12 MM
MDR report key: 1081877
·
Received July 21, 2008
Report
- Report Number
- 2647580-2008-00402
- Event Type
- Malfunction
- Date Received
- July 21, 2008
- Date of Event
- June 20, 2008
- Report Date
- June 23, 2008
- Manufacturer
- PONCE - USS
- Product Code
- GCJ
- PMA / PMN Number
- K924011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATE INITIAL REPORT SENT: 07/21/2008.
Description of Event or Problem · 1
PROCEDURE TYPE: LAP CHOLE. ACCORDING TO THE RPTR: DURING THE PROCEDURE, THE BALLOON BROKE WHILE IT WAS INFLATED WITH 20CC OF AIR. THERE WAS NO REPORT OF PIECES FALLING ONTO THE CAVITY OR IMPACTING THE PT. THE OPERATING TIME AND INCISION WERE NOT EXTENDED AS A RESULT. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO PT INJURY WAS REPORTED. PT STATUS: OK. NO FURTHER PT INFO AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPACEMAKER BLUNT TIP TROCAR 12 MM | DISPOSABLE SURGICAL ACCESS DEVICE | GCJ | PONCE - USS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |