MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-04-12 for ROTATOR SNARE 711120 manufactured by United States Endoscopy Group, Inc..
[3339795]
The rotator snare is intended to be used with diathermic energy for the endoscopic resection of polyps in the gastrointestinal tract. It was reported that during a procedure while the handle was rotated, the customer indicated that the cautery was "weak". They used another snare but this time also checked the diathermy settings and found no current going through. The customer chose to continue the procedure with a cold snare and proceeded to resect the polyp, which started to bleed. There was no reported harm or injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[10669202]
The company performed electrical connectivity testing on units from the same lot number, and those units all passed. The end user informed the distributor that they are not quite sure as to why this event occurred and that they are not suggesting that the snare device was the cause of this event at all. The facility indicated that they have new staff members on the unit who are unfamiliar with endoscopy and are looking at all of the variables involved. As result of our investigation, the distributor has offered the end user in-service training for their entire staff on all the products they use. Even though there was no reported harm or injury to the patient, us endoscopy is submitting this mdr because of the concern for non-cautery with the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1528319-2013-00028 |
| MDR Report Key | 3063615 |
| Report Source | 08 |
| Date Received | 2013-04-12 |
| Date of Report | 2013-04-12 |
| Date of Event | 2013-03-14 |
| Date Mfgr Received | 2013-03-14 |
| Device Manufacturer Date | 2012-06-01 |
| Date Added to Maude | 2013-06-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. CRAIG MOORE |
| Manufacturer Street | 5976 HEISELY RD. |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4406394494 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROTATOR SNARE |
| Generic Name | ROTATOR SNARE |
| Product Code | GAE |
| Date Received | 2013-04-12 |
| Model Number | 711120 |
| Catalog Number | 711120 |
| Lot Number | 70205 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNITED STATES ENDOSCOPY GROUP, INC. |
| Manufacturer Address | 5976 HEISELY RD. MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-12 |