MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-15 for VIA COMPLIANCE KIT 00719701 manufactured by United States Endoscopy Group, Inc..
[129183913]
The event occurred during an upper egd sampling procedure. A forceps device was inserted through the endoscope accessory channel and pushed the brush head into the duodenum. The brush head passed into the small intestine and the physician did not attempt retrieval. The double-header cleaning brush is included within the via compliance kit. The lot numbers of the procedure kit and the cleaning brush are unknown. The device subject of this event was not returned to us endoscopy for evaluation. The instructions for use include the following statements: "if the channels 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. Use only in channels 2. 0mm and larger and in control head valve openings. 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. " the facility accepted us endoscopy's offer of in-service training. The training was completed on (b)(6) 2018; no further issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[129183914]
The user facility reported that the brush head of a double-header cleaning brush became detached during cleaning and was retained in the endoscope accessory channel. The brush head was pushed into the patient during the next procedure. The physician chose not to retrieve the brush head, instead allowing it to pass naturally. There was no reported harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2018-00037 |
| MDR Report Key | 8073345 |
| Date Received | 2018-11-15 |
| Date of Report | 2018-11-15 |
| Date of Event | 2018-10-15 |
| Date Mfgr Received | 2018-10-18 |
| Date Added to Maude | 2018-11-15 |
| 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 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 | VIA COMPLIANCE KIT |
| Generic Name | COMPLIANCE KIT |
| Product Code | NWU |
| Date Received | 2018-11-15 |
| Model Number | 00719701 |
| Catalog Number | 00719701 |
| 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 | 2018-11-15 |