MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-10 for MICROLINE 3311 manufactured by Microline.
[82708167]
Microline tip inserted through trocar. Upon insertion it was noted that the insulation fell into the abdomen. Was immediately retrieved. Searched abdomen and field for 2nd half of insulation and was unable to retrieve. This product is currently on voluntary recall through microline. All education to staff was done prior in order to alert staff of recall and educate as to how to look crack in insulation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071546 |
| MDR Report Key | 6791547 |
| Date Received | 2017-08-10 |
| Date of Report | 2017-08-10 |
| Date of Event | 2017-08-09 |
| Date Added to Maude | 2017-08-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MICROLINE |
| Generic Name | CONTROL TIP DISSECTOR |
| Product Code | GDI |
| Date Received | 2017-08-10 |
| Model Number | 3311 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROLINE |
| Manufacturer Address | BEVERLY MA 01915 US 01915 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-10 |