MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-11-13 for NOVY CORNUAL CANNULATION SET J-NCS-503570 manufactured by Cook Urological Inc.
[18490431]
The clear plastic tip dislodged from the blue portion during chromotubation. It was easily retrieved with a hysteroscopic grasper. These are the doctors own words. He went on to say he does approx 50-100 of these per year and would like to work on a new, but similar device with some improvements. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
[18595667]
Due to the complaint device not being returned, a proper evaluation could not be performed. Two devices noting two different lot numbers wer retrieved from finished stock for evaluation. One guide catheter from the evaluation lots were test pulled and was noted to separate at the bond at 6. 9lbs, the other lot was also test pulled and was noted to separate at the bond 6. 5 lbs. Both guide catheters pulled within specification. Additional information has been requested from the physician without response at this time, when additional information is received, it will be forwarded. Unable to confirmed customers difficulty.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2009-00035 |
| MDR Report Key | 1531135 |
| Report Source | 99 |
| Date Received | 2009-11-13 |
| Report Date | 2009-11-11 |
| Date Mfgr Received | 2009-10-12 |
| Date Added to Maude | 2009-11-19 |
| 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 | NOVY CORNUAL CANNULATION SET |
| Generic Name | MOV CATHETER, SALPINGOGRAPHY |
| Product Code | MOV |
| Date Received | 2009-11-13 |
| Model Number | NA |
| Catalog Number | J-NCS-503570 |
| Lot Number | UNKNOWN |
| 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 | 2009-11-13 |