FDA Adverse Event
Malfunction
Summary report: N
+IO- 5MM GUARD TROCR (KIT2 SLV) 65MM W/GAS
MDR report key: 2133265
·
Received May 11, 2011
Report
- Report Number
- 2647580-2011-00304
- Event Type
- Malfunction
- Date Received
- May 11, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 8, 2011
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GCJ
- PMA / PMN Number
- K981941
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: UNK. ACCORDING TO THE REPORTER: SURGEON FOUND THAT ORANGE SCRAPS (COATING) WERE COMING OFF THE DEVICE WHILE PREPARING FOR SURGERY. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | +IO- 5MM GUARD TROCR (KIT2 SLV) 65MM W/GAS | DISPOSABLE SURGICAL ACCESS DEVICE | GCJ | USSC PUERTO RICO | P0G1026 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |