MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-18 for DOUBLE HEADER CHANNEL AND CONTROL HEAD COMBO 00711609 manufactured by United States Endoscopy Group, Inc..
[139184132]
The user facility name was not identified within the medwatch report and therefore, us endoscopy was unable to obtain additional information regarding the subject event. Based on the lot number provided in the medwatch report, the device history record (manufactured in may of 2018 with (b)(4) units) was reviewed by us endoscopy quality and confirmed that the brush was manufactured according to specifications; no abnormalities were identified. There have been no other complaints associated with the lot subject of the event. The user facility reported that a portion of the device was lodged in the port of an endoscope however, it is important to note that the double-header includes two brushes and it was not clear which brush or portion had detached. The double-header is intended for cleaning endoscope channels 2. 0mm and larger. Without endoscope information us endoscopy cannot confirm that the brush was compatible with the endoscope involved in this event. Statements in the instructions for use include: "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. Dispose of the cleaning brush after initial use. The mechanical attachment of the brush(es) to the plastic sheath cannot be guaranteed to be reliable or secure following initial use. " additionally, us endoscopy instructions for use states, "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. " in the event that us endoscopy receives additional information regarding the reported event a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[139184133]
Reference user facility medwatch report #5083189. There were no injuries associated with the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2019-00013 |
| MDR Report Key | 8429961 |
| Date Received | 2019-03-18 |
| Date of Report | 2019-03-18 |
| Date of Event | 2018-12-18 |
| Date Mfgr Received | 2019-02-19 |
| Device Manufacturer Date | 2018-05-10 |
| Date Added to Maude | 2019-03-18 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. COLETTA COHARA |
| Manufacturer Street | 5976 HEISLEY RD |
| 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 RD |
| 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 | 0 |
| Brand Name | DOUBLE HEADER CHANNEL AND CONTROL HEAD COMBO |
| Generic Name | CLEANING BRUSH |
| Product Code | MNL |
| Date Received | 2019-03-18 |
| Model Number | 00711609 |
| Catalog Number | 00711609 |
| Lot Number | 1808455 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNITED STATES ENDOSCOPY GROUP, INC. |
| Manufacturer Address | 5976 HEISLEY RD MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-18 |