FDA Adverse Event
Injury
Summary report: N
SPACEMAKER BLUNT TIP TROCAR 10 MM
MDR report key: 1253389
·
Received December 2, 2008
Report
- Report Number
- 2647580-2008-00675
- Event Type
- Injury
- Date Received
- December 2, 2008
- Date of Event
- November 7, 2008
- Report Date
- November 7, 2008
- Manufacturer
- PONCE - USS
- Product Code
- GCJ
- PMA / PMN Number
- K924011
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE INITIAL REPORT SENT: 12/02/2008.
Description of Event or Problem · 1
PROCEDURE TYPE: INGUINAL HERNIA REPAIR. ACCORDING TO THE RPTR: WHILE PUSHING THROUGH TROCAR TO PLACE THE MESH, THE RUBBER SEAL BROKE OFF, AND WAS PUSHED WITH THE MESH INTO THE ABDOMEN. THE PROCEDURE WAS CONVERTED TO OPEN TO REMOVE THE RUBBER SEAL FROM THE ABDOMEN. THE CASE WAS DELAYED APPROX 45 MINS TO 1 HR. NO BLEEDING. NO PT INJURY WAS REPORTED. NO ADD'L INFO AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPACEMAKER BLUNT TIP TROCAR 10 MM | DISPOSABLE SURGICAL ACCESS DEVICE | GCJ | PONCE - USS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Required Intervention |