MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-14 for CO2EFFICIENT ENDOSCOPIC INSUFFLATOR 710302 manufactured by United States Endoscopy Group, Inc..
[130974539]
The co2efficient endoscopic insufflator is designed to use co2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. The co2efficient device is designed to be connected to the endoscope via the air/water port. During the reported event, one co2efficient device was connected to the endoscope air/water port while the second co2efficient device was simultaneously connected to the endoscope accessory port. The connection of the co2efficient device to the accessory port of the endoscope is off-label use, and contrary to the device set-up instructions which are provided in the instructions for use. The cause of the event is attributed to the connection of the co2efficient device to the accessory port of the endoscope, which is off-label use and contrary to the set-up instructions provided in the instructions for use. Us endoscopy counseled the user facility that the insufflator usage associated with this event is not within the intended use, specifically that the co2efficient device is not labeled for use via the accessory port of an endoscope, and that no testing or validation has been performed to assess the safety or efficacy of using two endoscopic insufflators at the same time in two different endoscope ports. Us endoscopy offered formal in-service training to the user facility; however, the user facility declined. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[130974540]
The user facility reported bleeding of the mucosal lining due to over-insufflation during a transoral incisionless fundoplication (tif) procedure which included the simultaneous use of two co2efficient endoscopic insufflators. One of the insufflators was improperly connected to the endoscope via the accessory port, bypassing the air/water valve of the endoscope which is used to manage insufflation during endoscopic procedures. The user facility reported that the patient did not require treatment as a result of the reported event, and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2018-00041 |
| MDR Report Key | 8167112 |
| Date Received | 2018-12-14 |
| Date of Report | 2018-12-14 |
| Date of Event | 2018-11-15 |
| Date Mfgr Received | 2018-11-16 |
| Date Added to Maude | 2018-12-14 |
| 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 | 2018-12-14 |
| Model Number | 710302 |
| Catalog Number | 710302 |
| 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 | 2018-12-14 |