FDA Adverse Event
Malfunction
Summary report: N
SPACEMAKER BLUNT TIP TROCAR 10MM
MDR report key: 3192545
·
Received June 19, 2013
Report
- Report Number
- 2647580-2013-00333
- Event Type
- Malfunction
- Date Received
- June 19, 2013
- Date of Event
- May 15, 2013
- Report Date
- June 5, 2013
- Manufacturer
- COVIDIEN, FORMERLY USSC PUERTO RICO
- Product Code
- GCJ
- PMA / PMN Number
- K924011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: EXTRA PERITONEAL LYMPHATIC DISSECTION. ACCORDING TO THE REPORTER: WHEN FILLING THE BALLOON WITH 17CC OF SALINE SOLUTION, THE BALLOON BURST. A SECOND DEVICE WAS REQUIRED, AND FUNCTIONED NORMALLY WITHOUT FURTHER CONSEQUENCE. NO PT INJURY OR ILL-EFFECTS, NO MEDICAL INTERVENTION REQUIRED, NO UNANTICIPATED TISSUE LOSS, TISSUE DAMAGE OR BLEEDING. NO EXTENSION TO SURGICAL TIME REQUIRED, NOTHING FELL IN THE SURGICAL CAVITY. PT CURRENT STATUS REPORTED AS RECOVERED. BOTH DEVICES ARE BEING RETURNED: THE ONE THAT BURST, AND THE SECOND THAT WAS USED THAT FUNCTIONED NORMALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 278792 | SPACEMAKER BLUNT TIP TROCAR 10MM | SPACEMEKER BALLOONS | GCJ | COVIDIEN, FORMERLY USSC PUERTO RICO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |