FDA Adverse Event
Malfunction
Summary report: N
SPACEMAKER BLUNT TIP TROCAR 12MM
MDR report key: 3190606
·
Received June 13, 2013
Report
- Report Number
- 2647580-2013-00323
- Event Type
- Malfunction
- Date Received
- June 13, 2013
- Date of Event
- May 16, 2013
- Report Date
- May 21, 2013
- Manufacturer
- COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
- Product Code
- GCJ
- PMA / PMN Number
- K924011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: LAPAROSCOPIC CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: THE BALLOON RUPTURED WITH AN EXPLOSION SOUND. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 269853 | SPACEMAKER BLUNT TIP TROCAR 12MM | DISPOSABLE SURGICAL ACCESS DEVICE | GCJ | COVIDIEN, FORMERLY USSC PUERTO RICO, INC. | NOT AVAILABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |