FDA Adverse Event
Malfunction
Summary report: N
DEROYAL
MDR report key: 3928397
·
Received June 20, 2014
Report
- Report Number
- 3005011024-2014-00006
- Event Type
- Malfunction
- Date Received
- June 20, 2014
- Date of Event
- August 20, 2013
- Report Date
- August 20, 2013
- Manufacturer
- DEROYAL INDUSTRIES, INC.
- Product Code
- KDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEROYAL: THE REPORTED SAMPLE WAS NOT RETURNED FOR EVALUATION. AFTER OBTAINING FURTHER INFORMATION, IT HAS BEEN CONCLUDED THAT THE INSUFFLATION TUBING WAS BEING UTILIZED OUTSIDE ITS INTENDED USE. AS A CORRECTIVE ACTION WE ARE CHANGING THE NAME OF THE FINISH GOOD. THIS WAY IT CAN BE FURTHER IDENTIFIED THAT INSUFFLATION TUBING IS INTENDED TO DELIVER CARBON DIOXIDE GAS FROM THE INSUFFLATOR TO THE PATIENT TO ASSIST IN CREATING PNEUMOPERITONEUM DURING LAPAROSCOPIC PROCEDURES ONLY.
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT THE INSUFFLATION TUBING FILTER IS NOT WORKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 363390 | DEROYAL | KIT, SURGICAL INSTRUMENT, DISPOSABLE | KDD | DEROYAL INDUSTRIES, INC. | 31535315 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |