MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-10 for EXACTO COLD SNARE 00711115 manufactured by United States Endoscopy Group, Inc..
[108262157]
The exacto cold snare is intended to be used without diathermic energy for the endoscopic resection of polyp tissue in the gastrointestinal tract. The report indicates that the doctor was unable to fully retract the snare, resulting in failure to completely resect a polyp. The tissue was instead pulled to free the polyp, with a resultant small bleed. The bleed was described as "small". However, cautery was applied to the bleed site. The subject device was returned to use. The device was evaluated and found to be intact and functional, with no evidence of damage to the sheath. The device history record was reviewed and confirmed the device was manufactured to specification. No other complaints of any type are associated with exacto cold snare units from the lot (00711115 lot 1711589). The following statements are included in the instructions for use: "disengage the snare from the polyp if there is a risk of complication. 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. 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. Insert the device into the biopsy port of the endoscope using short strokes, approximately 1"-1. 5" (2. 5cm - 3. 8cm) in length throughout device passage to avoid sheath kinking. " response is pending on the offer of in-service.
Patient Sequence No: 1, Text Type: N, H10
[108262158]
The user facility reported the exacto cold snare sheath became buckled and the device failed to completely resect a polyp. The tissue was instead pulled to free the polyp, with a resultant small bleed. Cautery was applied at the site of the bleed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2018-00015 |
| MDR Report Key | 7504010 |
| Date Received | 2018-05-10 |
| Date of Report | 2018-05-10 |
| Date of Event | 2018-03-12 |
| Date Mfgr Received | 2018-04-11 |
| Device Manufacturer Date | 2017-07-18 |
| Date Added to Maude | 2018-05-10 |
| 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 | 2018-05-10 |
| Model Number | 00711115 |
| Catalog Number | 00711115 |
| Lot Number | 1711589 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-10 |