MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-07-13 for DEROYAL INSUFFLATION TUBING WITH .3 MICRO FIT. 28-0211 manufactured by Deroyal Industries, Inc..
[2062245]
Surgeons repeatedly are complaining that the tubing is extremely slow to insufflate. Complaints of defective product and maybe the filters are bad. This has occurred during multiple cases of laparoscopic surgery. Insufflating the abdomen using this tubing was very slow. This slowed the progress of surgery. At least six tubings were pulled and demonstrated the same problem.
Patient Sequence No: 1, Text Type: D, B5
[9212457]
Completed with info provided by the user facility. After analysis of the device components and other possible root causes, it was determined that the insufflation tubing reported may become occluded due to housing material. The plasticizer may migrate from the tubing into the filter housing causing an occlusion. Heat has also been determined to precipitate the occlusion. Through extensive testing and research, a decision was made to change the filter housing material to (b)(4). (b)(4) is a stronger, higher impact and more chemically resistant material. It is also less affected by higher temperatures. We are confident this action has eliminated the tubing issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1033554-2011-00003 |
| MDR Report Key | 2195159 |
| Report Source | 05,06,07 |
| Date Received | 2011-07-13 |
| Date of Report | 2010-12-03 |
| Date of Event | 2010-12-03 |
| Date Facility Aware | 2010-12-03 |
| Report Date | 2010-12-03 |
| Date Mfgr Received | 2010-12-05 |
| Date Added to Maude | 2012-05-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 700 MARTIN LUTHER KING, JR. BLVD |
| Manufacturer City | SANDORD FL 32771 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32771 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL INSUFFLATION TUBING WITH .3 MICRO FIT. |
| Generic Name | TUBING WITH FILTER, INSUFFLATION |
| Product Code | NKC |
| Date Received | 2011-07-13 |
| Catalog Number | 28-0211 |
| Lot Number | 24085731 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-07-13 |