MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-24 for AQUSHIELD SYSTEM CO2 - FUJINON 00711553 manufactured by United States Endoscopy Group, Inc..
[83747850]
Review of the device history record indicates no issues during manufacture; the device was manufactured to specification. The subject device was not returned to us endoscopy. The instructions for use contain the following: "prime the air/water channel prior to insertion of the endoscope into a patient. If water pressure is low, check to see that the lid cap is tightly closed. Check that the endoscope connector is firmly attached to the endoscope. " device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[83747851]
The aquashield system co2 - fujinon is intended to be used with an air or carbon dioxide (co2) source from an endoscope with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with u. S. Commercially available sterile water bottles. This device is intended to be used for not more than 24 hours. The user facility reported during a procedure the connection between the aquashield system co2 and the endoscope was leaking sterile water. There was no report of injury to the patient or the user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2017-00023 |
| MDR Report Key | 6817349 |
| Date Received | 2017-08-24 |
| Date of Report | 2017-08-24 |
| Date of Event | 2017-07-31 |
| Date Mfgr Received | 2017-07-31 |
| Device Manufacturer Date | 2017-05-25 |
| Date Added to Maude | 2017-08-24 |
| 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 | AQUSHIELD SYSTEM CO2 - FUJINON |
| Generic Name | WATER BOTTLE CAP |
| Product Code | FEQ |
| Date Received | 2017-08-24 |
| Model Number | 00711553 |
| Catalog Number | 00711553 |
| Lot Number | 1708707 |
| Device Expiration Date | 2018-05-25 |
| Operator | PHYSICIAN |
| 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 | 1. Other | 2017-08-24 |