MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-02-25 for PULL THRU STUBBY BRUSH 100405 manufactured by Medivators.
[137113839]
The facility reported pieces from a pull thru stubby brush breaking off inside an endoscope while staff pre-cleaned the endoscope. The pieces fell inside a patient during the subsequent patient procedure thus there is risk of cross-contamination. While performing an egd procedure with an olympus gif-hq190 series endoscope the physician detected pieces from a pull thru brush inside a patient when using the forceps in the biopsy channel. The physician then removed the pieces. It was reported the facility's endoscope technician had manually cleaned the endoscope, but they did not notice the pieces were missing from the pull thru stubby brush. The facility sent the endoscope to the manufacture for repair. Medivators has not been informed of their results. The pull thru brush was not returned for investigation. No adverse event reported. This will continue to be monitored in the medivators complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[137113840]
The facility reported pieces from a pull thru stubby brush breaking off inside an endoscope while staff pre-cleaned the endoscope. The pieces fell inside a patient during the subsequent patient procedure thus there is risk of cross-contamination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651395-2019-00002 |
| MDR Report Key | 8368460 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-02-25 |
| Date of Report | 2019-02-25 |
| Date of Event | 2019-01-30 |
| Date Mfgr Received | 2019-01-30 |
| Device Manufacturer Date | 2018-12-11 |
| Date Added to Maude | 2019-02-25 |
| 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 | LAUREN JOHNSON |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer G1 | MEDIVATORS |
| Manufacturer Street | 3150 POLLOCK DRIVE |
| Manufacturer City | CONROE TX 77303 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77303 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PULL THRU STUBBY BRUSH |
| Generic Name | ENDOSCOPE CLEANING BRUSH |
| Product Code | MNL |
| Date Received | 2019-02-25 |
| Model Number | 100405 |
| Lot Number | 944114 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS |
| Manufacturer Address | 3150 POLLOCK DRIVE CONROE TX 77303 US 77303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-25 |