MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2010-12-01 for DEROYAL INSUFFLATION TUBING WITH FILTER 28-0210 manufactured by Deroyal Industries, Inc..
[1830699]
Laparoscopic insufflation tubing with apparent restricted flow during surgery resulted in limited pneumoperitoneum and extended anesthesia time for the pt.
Patient Sequence No: 1, Text Type: D, B5
[8807068]
The mfr's device investigation revealed the plasticizer in the tubing migrated and softened the filter housing material causing an occlusion. Heat was found to aggravate the action. The filter housing material was subsequently changed to polycarbonate which is a stronger, higher impact and more chemically resistant material also less affected by higher temperatures. This action has eliminated the occlusion issues as reported by the facility. The customer has also advised there was no injury or illness due to the device malfunction, however; it did prolong surgery time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004605321-2010-00002 |
| MDR Report Key | 1932153 |
| Report Source | 06,07 |
| Date Received | 2010-12-01 |
| Date of Report | 2010-07-02 |
| Date of Event | 2010-07-02 |
| Date Facility Aware | 2010-07-02 |
| Report Date | 2010-07-02 |
| Date Mfgr Received | 2010-07-02 |
| Date Added to Maude | 2011-02-09 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Street | 200 DEBUSK LN |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653621025 |
| Manufacturer G1 | DEROYAL INTERCONTINENTAL, S.A. |
| Manufacturer Street | KM7 AUTOPISTA JOAQUIN BALAGUER PISANO FREE ZONE, BLDG 49 |
| Manufacturer City | SANTIAGO |
| Manufacturer Country | DR |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL INSUFFLATION TUBING WITH FILTER |
| Generic Name | INSUFFLATION TUBING AND FILTER |
| Product Code | NKC |
| Date Received | 2010-12-01 |
| Catalog Number | 28-0210 |
| Lot Number | 21775446 |
| Device Expiration Date | 2013-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | POWELL TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-12-01 |