MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-31 for EXACTO COLD SNARE 00711115 manufactured by United States Endoscopy Group, Inc..
[119342754]
The exacto cold snare is intended to be used without diathermic energy for the endoscopic resection of polyp tissue in the gastrointestinal tract. The device history record was reviewed and confirmed the devices were manufactured to specification. There have been no other complaints associated with this lot. The device subject of this complaint was not returned to us endoscopy for evaluation. The instructions for use include the following statements: "the following conditions may cause the device to function improperly: advancing the handle to the open position with too much speed or force, attempting to pass or open the device in an extremely articulated endoscope, attempting to actuate the device in an extremely coiled position, actuating the device when the handle is at an acute angle in relation to the sheath. " the event is being filed in response to the vigilance report received.
Patient Sequence No: 1, Text Type: N, H10
[119342755]
Us endoscopy received a vigilance report from the (b)(6) stating that during a polypectomy procedure the exacto snare failed to deploy requiring replacement of the device. No patient or user harm was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2018-00027 |
| MDR Report Key | 7836652 |
| Date Received | 2018-08-31 |
| Date of Report | 2018-08-31 |
| Date of Event | 2018-07-31 |
| Date Mfgr Received | 2018-08-03 |
| Device Manufacturer Date | 2018-05-10 |
| Date Added to Maude | 2018-08-31 |
| 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 | EXACTO COLD SNARE |
| Generic Name | COLD SNARE |
| Product Code | FGX |
| Date Received | 2018-08-31 |
| Model Number | 00711115 |
| Catalog Number | 00711115 |
| Lot Number | 1808208 |
| 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 | 2018-08-31 |