MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-09-14 for NOVY CORNUAL CANNULATION SET J-NCS-503570 manufactured by Cook Urological Inc..
[20216681]
The tip of the cannula broke off inside the fallopian tube and they had to mechanically remove it for about 20 minutes. A clear plastic tip at the end of the cannula broke off in the fallopian tube. The surgeon was required to use mechanic extraction technique to remove adding 20 minutes of surgery time. Surgeon performing tubal anastomosis so, this also puts the patient's fallopian tube at risk of trauma. Fertility is the main purpose of this patient's surgery so, disappointment from the surgeon was significant.
Patient Sequence No: 1, Text Type: D, B5
[20404140]
At this time, the device has not been returned for evaluation and limited information received concerning the portion that separated. The customer indicated the separated portion was removed from the patient within the same procedure noting additional 20 minutes to retrieve the portion. On receipt of additional information and the device, an evaluation will be conducted and a follow-up report will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2010-00037 |
| MDR Report Key | 1845356 |
| Report Source | 05,06 |
| Date Received | 2010-09-14 |
| Date of Event | 2010-08-11 |
| Report Date | 2010-09-14 |
| Date Mfgr Received | 2010-08-17 |
| Device Manufacturer Date | 2008-07-16 |
| Date Added to Maude | 2010-09-29 |
| 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, RA |
| 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 | NOVY CORNUAL CANNULATION SET |
| Generic Name | MOV CATHETER, SALPINGOGRAPHY |
| Product Code | MOV |
| Date Received | 2010-09-14 |
| Model Number | NA |
| Catalog Number | J-NCS-503570 |
| Lot Number | U1750271 |
| Device Expiration Date | 2011-06-30 |
| 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 | 2010-09-14 |