MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-25 for COOK CL-2612-AC G46211 manufactured by Cook.
[66078369]
Wire broke off into patient. The wire was found in the specimen at the end of the procedure. Diagnosis or reason for use: turp. Is the product compounded: no. Is the product over-the-counter: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067511 |
| MDR Report Key | 6282843 |
| Date Received | 2017-01-25 |
| Date of Report | 2017-01-25 |
| Date of Event | 2017-01-10 |
| Date Added to Maude | 2017-01-27 |
| 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 | COOK |
| Generic Name | CUTTING LOOP 26 FR, .012, .012" WIRE |
| Product Code | KOB |
| Date Received | 2017-01-25 |
| Model Number | CL-2612-AC |
| Catalog Number | G46211 |
| Lot Number | 6980418 |
| Device Expiration Date | 2019-05-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK |
| Manufacturer Address | BLOOMINGDALE IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-25 |