MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-17 for EXACTO COLD SNARE 00711115 manufactured by United States Endoscopy Group, Inc..
[124345437]
The exacto cold snare is intended to be used without diathermic energy for the endoscopic resection of polyp tissue in the gastrointestinal tract. The user facility personnel reported the loop was partially separated from the control wire upon first deployment of the snare while inside the patient. 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 event was not returned to us endoscopy for evaluation. The user facility personnel mistakenly retained and returned the second, intact snare. The instructions for use include the following statements: "prior to clinical use, inspect and familiarize yourself with the device. If there is evidence of damage, do not use this product and contact your local product specialist. Remove the device from the package and uncoil the entire device and drape in a "u" shaped configuration, holding the proximal end in one hand and the distal sheath in the opposite hand. Move the finger rings back and forth to confirm that the snare loop opens and closes smoothly prior to inserting into the endoscope. Ensure the snare loop is fully retracted into the catheter prior to insertion into the endoscope. Short strokes, 1"-1. 5" (2. 5cm - 3. 8cm) in length, are recommended throughout device passage to avoid sheath kinking. 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. " the user facility has declined offer of in-service training.
Patient Sequence No: 1, Text Type: N, H10
[124345438]
The user facility reported the snare loop became partially detached from the exacto cold snare during procedural use. The device was replaced with a second exacto cold snare and the procedure was completed. There was no reported harm to patient or user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2018-00034 |
| MDR Report Key | 7975168 |
| Date Received | 2018-10-17 |
| Date of Report | 2018-10-17 |
| Date of Event | 2018-09-17 |
| Date Mfgr Received | 2018-09-17 |
| Device Manufacturer Date | 2018-06-15 |
| Date Added to Maude | 2018-10-17 |
| 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 | 2018-10-17 |
| Model Number | 00711115 |
| Catalog Number | 00711115 |
| Lot Number | 1810441 |
| 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 | 2018-10-17 |