MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-09-30 for COOK ECHOTIP A.R.T. WITH CHIBA BEVEL OVUM ASPIRATION NEEDLE K-J-ANC-17R-33 manufactured by Cook Urological Inc..
[1836118]
The patient experienced excessive bleeding post operative. The patient was admitted to the hospital approximately 10 hours after procedure. A laparoscopic procedure was performed an over 3 liters of blood was drained. The patient has recovered from this event.
Patient Sequence No: 1, Text Type: D, B5
[8687362]
A proper evaluation cannot be performed due to the facility not returning the device. The customer was contacted for additional information noting the contact indicated they are not sure it's the needle causing the issue. The nurse is checking with the physician to see if our sales representative could observe one of the procedures. At this time, the root cause cannot be confirmed, should additional information become available, it will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2010-00043 |
| MDR Report Key | 1869421 |
| Report Source | 05 |
| Date Received | 2010-09-30 |
| Report Date | 2010-09-30 |
| Date Mfgr Received | 2010-09-01 |
| Date Added to Maude | 2010-10-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRIS KILANDER |
| Manufacturer Street | 1100 W. MORGAN |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal | 47460 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK ECHOTIP A.R.T. WITH CHIBA BEVEL OVUM ASPIRATION NEEDLE |
| Generic Name | MQE NEEDLE, ASSISTED REPRODUCTION |
| Product Code | MQE |
| Date Received | 2010-09-30 |
| Model Number | NA |
| Catalog Number | K-J-ANC-17R-33 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK UROLOGICAL INC. |
| Manufacturer Address | SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-09-30 |