FDA Adverse Event
Malfunction
Summary report: N
CUSTOM PAK
MDR report key: 3123713
·
Received May 15, 2013
Report
- Report Number
- 3002037047-2013-00038
- Event Type
- Malfunction
- Date Received
- May 15, 2013
- Report Date
- April 16, 2013
- Manufacturer
- ALCON - BELGIUM / S.A. - ALCON-COUVREUR N.V.
- Product Code
- KYG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS IN PROGRESS. SAMPLES HAVE NOT YET BEEN RECEIVED FOR EVAL. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO METAL PARTICLES WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO THE MFR'S ACCEPTANCE CRITERIA. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED SEEING "MINOR METAL PARTICLES" IN THE PARACENTESIS AFTER USING A KNIFE DURING SURGERY. IT WAS REPORTED THAT THE METAL PARTICLES ARE TOO SMALL TO GRAB AND WERE LEFT IN THE EYE. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 214469 | CUSTOM PAK | CONVENIENCE KIT | KYG | ALCON - BELGIUM / S.A. - ALCON-COUVREUR N.V. | CUSTOM PAK | 353820 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CLEARCUT SIDE PORT KNIFE 1.2MM ANGLE |