MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-30 for CO2EFFICIENT ENDOSCOPIC INSUFFLATOR 710302 manufactured by United States Endoscopy Group, Inc..
[129888824]
The co2 efficient endoscopic insufflator is designed to use co2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. Through follow up with the user facility, us endoscopy learned the co2 efficient device and a second insufflator device were simultaneously connected at two different endoscope ports for use during the procedure. The user facility has declined to provide any further information regarding the patient's condition; the source of the abdominal pain is not known to us endoscopy. The serial number of the co2 efficient device subject of this event is unknown to us endoscopy and the device was not returned to us endoscopy for evaluation. The instructions for use include the following statements: "the co2 efficient endoscopic insufflator should be used only for an endoscopic procedure when insufflation of the gastrointestinal tract is necessary to support navigation of the endoscope and perform any evaluation procedures through the endoscope, and should therefore not be used for any other treatments. Do not attempt to use this system until you have completed all the steps in 'assembly prior to use' and 'setting-up for the procedure. Insert the connector on the tubing set to the gas output connection on the unit's front panel. It is important to use only us endoscopy manufactured high flow tubing labeled as us endoscopy co2 endoscopic tubing set (that includes a less than or equal to 0. 1 micron hydrophobic filter) designed to provide optimum performance. " us endoscopy has informed the user that the reported usage is not within the intended use of the device and that no testing or validation has been performed to assess for safety and efficacy of using two different endoscopic insufflators at the same time in two different endoscope ports. The co2 efficient instruction for use have also been reviewed with the user.
Patient Sequence No: 1, Text Type: N, H10
[129888825]
The user facility reported that a patient complained of abdominal pain and was admitted to the hospital following a transoral incisionless fundoplication (tif) procedure which included use of a co2 efficient endoscopic insufflator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2018-00039 |
| MDR Report Key | 8120144 |
| Date Received | 2018-11-30 |
| Date of Report | 2018-12-14 |
| Date of Event | 2018-10-31 |
| Date Mfgr Received | 2018-11-02 |
| Date Added to Maude | 2018-11-30 |
| 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 | CO2EFFICIENT ENDOSCOPIC INSUFFLATOR |
| Generic Name | ENDOSCOPIC INSUFFLATOR |
| Product Code | FCX |
| Date Received | 2018-11-30 |
| Model Number | 710302 |
| Catalog Number | 710302 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-11-30 |