MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-08 for CO2MPACT ENDOSCOPIC INSUFFLATOR 00710300 manufactured by United States Endoscopy Group, Inc..
[77207679]
The co2mpact endoscopic insufflator is used to provide co2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. The rate of flow of co2 during the procedure is set by the user. In addition, the user controls co2 output by depressing or releasing the air/water valve on the endoscope. The perforation occurred during use of an electrosurgical cutting device to separate esophageal tissue layers during a poem procedure. The poem procedure also included the use of co2 insufflation, and the use of a distal attachment device. The distal attachment device is a transparent ring placed on the distal tip of the endoscope to facilitate observation of tissue during endoscopic procedures. Us endoscopy is not the manufacturer of the distal attachment device or the electrosurgical cutting device. Through investigation into this event, us endoscopy learned that the distal attachment device was modified by the user prior to use in the procedure. There was no report of a malfunction of the co2mpact device. No malfunction of device reported.
Patient Sequence No: 1, Text Type: N, H10
[77207680]
The user facility reported an esophageal perforation occurred during a peroral endoscopic myotomy (poem) procedure, which involved tunneling between layers of esophageal tissue. Clips were applied to the perforation and the patient was further treated in laparoscopic surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2017-00018 |
| MDR Report Key | 6623415 |
| Date Received | 2017-06-08 |
| Date of Report | 2017-06-08 |
| Date of Event | 2017-05-11 |
| Date Mfgr Received | 2017-05-11 |
| Device Manufacturer Date | 2016-01-15 |
| Date Added to Maude | 2017-06-08 |
| 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 | CO2MPACT ENDOSCOPIC INSUFFLATOR |
| Generic Name | CO2 INSUFFLATOR |
| Product Code | FCX |
| Date Received | 2017-06-08 |
| Model Number | 00710300 |
| Catalog Number | 00710300 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Hospitalization | 2017-06-08 |