MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-13 for REVEAL DISTAL ATTACHMENT CAP 00711770 manufactured by United States Endoscopy Group, Inc..
[136626999]
Through follow up with the user facility, us endoscopy has learned that medical tape was not used to secure the cap, which is contrary to the directions provided in the instructions for use. Statements in the instructions for use include: "dry the tip of the endoscope by wiping with a 4x4 gauze, or dry wash cloth. It is important that the reveal distal attachment cap and tip of the endoscope are dry to ensure that the device stays attached to the endoscope. Secure the reveal distal attachment cap to the endoscope using medical grade tape ensuring not to cover the side hole. " the device subject of this event was not returned to us endoscopy for evaluation. The user facility returned other devices from the same lot, which were evaluated and found to be within specification. The device history record for the subject lot was reviewed and confirmed the device was manufactured to specification. There have been no other complaints associated with this lot. The user facility has declined us endoscopy's offer of in-service training.
Patient Sequence No: 1, Text Type: N, H10
[136627000]
The user facility reported that a reveal distal attachment cap detached from the endoscope during procedural use. The device was retrieved, and there was no reported harm to the patient or user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2019-00010 |
| MDR Report Key | 8336203 |
| Date Received | 2019-02-13 |
| Date of Report | 2019-02-13 |
| Date Mfgr Received | 2019-01-14 |
| Device Manufacturer Date | 2018-09-04 |
| Date Added to Maude | 2019-02-13 |
| 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 | REVEAL DISTAL ATTACHMENT CAP |
| Generic Name | DISTAL ATTACHMENT CAP |
| Product Code | OCX |
| Date Received | 2019-02-13 |
| Model Number | 00711770 |
| Catalog Number | 00711770 |
| Lot Number | 1814922 |
| 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 | 2019-02-13 |