FDA Adverse Event
Malfunction
Summary report: N
SPACEMAKER BLUNT TIP TROCAR 10MM
MDR report key: 1861258
·
Received October 1, 2010
Report
- Report Number
- 2647580-2010-00804
- Event Type
- Malfunction
- Date Received
- October 1, 2010
- Date of Event
- September 7, 2010
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GCJ
- PMA / PMN Number
- K924011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: WHEN THE MESH WAS INSERTED THE GREY SEAL INSIDE THE CANNULA WENT INTO THE PATIENT AS WELL. THIS IS NOT USUAL. AFTER FOREIGN BODY WAS REMOVED CARRIED ON WITH THE PRODUCT. UNDER 30 MINUTES EXTRA OPERATING TIME AND NO EXTRA BLOOD LOSS. NO TISSUE DAMAGE TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPACEMAKER BLUNT TIP TROCAR 10MM | DISPOSABLE SURGICAL ACCESS DEVICE | GCJ | USSC PUERTO RICO | P0E0619 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |