MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-03-01 for 1MM MICROBIOLOGY BRUSH 130 manufactured by Conmed Corporation.
[101314398]
The reported device is being returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.
Patient Sequence No: 1, Text Type: N, H10
[101314399]
Conmed received a medwatch report submitted by the user facility. In this report, the user facility stated that post bronchoscopy procedure, the 130 microbiology brush's tip was noticed to be missing. Attempts were made to search for the detached tip on the patient and in the bronchial lavage, but the device's tip was not found. Upon multiple attempts to gather information, the reporter stated that no additional information regarding the patient status or procedure will be made available. The only information provided is the medwatch, which makes no mention/report of any procedural delays or patient injury. This report is raised on the basis of a reported malfunction, due to which, part of the device detached and it's location is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2018-00046 |
| MDR Report Key | 7307637 |
| Report Source | OTHER |
| Date Received | 2018-03-01 |
| Date of Report | 2018-03-01 |
| Date of Event | 2018-01-25 |
| Date Mfgr Received | 2018-02-06 |
| Device Manufacturer Date | 2017-09-27 |
| Date Added to Maude | 2018-03-01 |
| 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 | MRS. MARTHA CAMACHO URRIBARRI |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243051 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 13502 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1MM MICROBIOLOGY BRUSH |
| Generic Name | PULMONARY MICROBIOLOGY BRUSHES |
| Product Code | BTG |
| Date Received | 2018-03-01 |
| Catalog Number | 130 |
| Lot Number | 201709274 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 13502 US 13502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-01 |