MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-03 for GEMINI DOUBLE ENDED CHANNEL CLEANING BRUSH HZ711607 manufactured by United States Endoscopy Group, Inc..
[178331073]
The user facility did not disclose the lot number subject of the reported event. The detached brush head component of the subject device has been returned to steris endoscopy for evaluation, however a full evaluation could not be completed with the partial device. Following the reported event, the distributor provided in-service training to the user facility referencing the endoscope (fuji eg-l580nw7) instructions for use and instructed the users to check the brush after cleaning. The gemini cleaning brush instructions for use include the following statements: "original equipment manufacturer's guidelines regarding the care and cleaning of individual endoscope channels must be reviewed prior to the use of any cleaning brush. If the channel(s) are known to be occluded or resistance is met in attempting to pass the brush through the endoscope, do not force the cleaning brush through the endoscope, as this may result in damage to the channel. " there have been no further issues reported.
Patient Sequence No: 1, Text Type: N, H10
[178331154]
The distributor reported that the brush head from a gemini double ended cleaning brush was pushed out of the endoscope during a patient procedure. The brush head was retrieved and there was no report of harm to the patient or user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2020-00002 |
| MDR Report Key | 9548185 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-03 |
| Date of Report | 2020-01-03 |
| Date of Event | 2019-11-22 |
| Date Mfgr Received | 2019-12-09 |
| Date Added to Maude | 2020-01-03 |
| 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. COLETTA COHARA |
| Manufacturer Street | 5976 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403586251 |
| Manufacturer G1 | UNITED STATES ENDOSCOPY GROUP, INC. |
| Manufacturer Street | 5976 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEMINI DOUBLE ENDED CHANNEL CLEANING BRUSH |
| Generic Name | CLEANNG BRUSH |
| Product Code | MNL |
| Date Received | 2020-01-03 |
| Model Number | HZ711607 |
| Catalog Number | HZ711607 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNITED STATES ENDOSCOPY GROUP, INC. |
| Manufacturer Address | 5976 HEISLEY ROAD MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-03 |