MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-19 for DISPOSABLE TWO-PART TROCAR NEEDLE 090020 manufactured by Cook Inc.
[131375454]
Common name: trocar, gastro-urology. Pro-code: fbq. Pma/510k #: exempt. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[131375455]
It is reported that during unspecified procedure(s) using disposable two-part trocar needles, the inner stylet drags and makes an audible grinding sound as its passing through the device. On an unknown number of occasions, it is reported that the "device is shearing coating off wires as it's passing through". It is unknown if there have been any patient adverse effects as a result. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-03684 |
| MDR Report Key | 8179031 |
| Date Received | 2018-12-19 |
| Date of Report | 2019-01-07 |
| Date of Event | 2018-12-04 |
| Date Mfgr Received | 2018-12-04 |
| Date Added to Maude | 2018-12-19 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC. |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DISPOSABLE TWO-PART TROCAR NEEDLE |
| Product Code | FBQ |
| Date Received | 2018-12-19 |
| Catalog Number | 090020 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-19 |