MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-30 for RAPTOR GRASPING DEVICE 00711177 manufactured by United States Endoscopy Group, Inc..
[119037997]
The disposable raptor grasping device is intended to be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures. The stent was confirmed to be in the correct position after the raptor was released; no further intervention was required. The lot number of the device subject of this complaint was unknown and the device 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. " us endoscopy has offered in-service training to the user facility and the facility response is pending.
Patient Sequence No: 1, Text Type: N, H10
[119037998]
The user facility reported during a stent positioning procedure, the raptor grasping device failed to release from the stent. The user facility cut the handle from the raptor device to free the stent and the procedure was completed. There was no report of harm to the patient or user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2018-00026 |
| MDR Report Key | 7833903 |
| Date Received | 2018-08-30 |
| Date of Report | 2018-10-12 |
| Date of Event | 2018-07-31 |
| Date Mfgr Received | 2018-07-31 |
| Date Added to Maude | 2018-08-30 |
| 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 | RAPTOR GRASPING DEVICE |
| Generic Name | GRASPING DEVICE |
| Product Code | OCZ |
| Date Received | 2018-08-30 |
| Model Number | 00711177 |
| Catalog Number | 00711177 |
| 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 | 2018-08-30 |