MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-02-26 for ASCENT REPROCESSED TROCAR B5LT manufactured by Ascent Healthcare Solutions.
[21651404]
Surgeon opened reprocessed sterile trocar when he saw a red substance on the outside of the trocar. Surgeon gave the contaminated trocar to assistant and it was returned to ascent, the reprocessing company for analysis. Lab analysis conducted by ascent determined that the substance was hemoglobin. We do not feel that their lack of urgency or attention to this matter was appropriate for the seriousness of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014996 |
| MDR Report Key | 1623587 |
| Date Received | 2010-02-26 |
| Date of Report | 2010-02-26 |
| Date of Event | 2010-01-29 |
| Date Added to Maude | 2010-03-16 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASCENT REPROCESSED TROCAR B5LT |
| Generic Name | TROCAR |
| Product Code | NMK |
| Date Received | 2010-02-26 |
| Returned To Mfg | 2010-02-01 |
| Model Number | B5LT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENT HEALTHCARE SOLUTIONS |
| Manufacturer Address | 10232 SOUTH 51ST PHOENIX AZ 85044 US 85044 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-02-26 |