MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-25 for EXACTO COLD SNARE 00711115 manufactured by United States Endoscopy Group, Inc..
[115391099]
The exacto cold snare is intended to be used without diathermic energy for the endoscopic resection of polyp tissue in the gastrointestinal tract. Device subject of the report was not available for investigation. The device history record for the subject lot was reviewed and showed the product was made to specification with no noted issues. No other complaints have been received associated with this lot. Several attempts were made to contact the user facility, however the user facility has refused to provide additional information. The instructions for use include the following statements: "the following conditions may not allow the device to function properly or cause patient injury: attempting to advance 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 and/or, attempting to actuate the device when the handle is at an acute angle in relation to the sheath".
Patient Sequence No: 1, Text Type: N, H10
[115391100]
Us endoscopy received a vigilance report from the health authority in (b)(6) (ansm) stating that during a polypectomy procedure the exacto snare failed to deploy requiring replacement of the device. The report described prolonged bleeding with extended procedure time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2018-00021 |
| MDR Report Key | 7720397 |
| Date Received | 2018-07-25 |
| Date of Report | 2018-08-02 |
| Date of Event | 2018-06-01 |
| Date Mfgr Received | 2018-06-26 |
| Device Manufacturer Date | 2017-08-17 |
| Date Added to Maude | 2018-07-25 |
| 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 | 2018-07-25 |
| Model Number | 00711115 |
| Catalog Number | 00711115 |
| Lot Number | 1713096 |
| 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 | 2018-07-25 |