MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-19 for RAPTOR GRASPING DEVICE 00711177 manufactured by United States Endoscopy Group, Inc..
[131379510]
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. Upon removal of the first raptor device from the scope, the device was observed to be missing a jaw component. The user could not locate the detached component, and was unsure if the component was retained in the patient or became detached after device removal from the scope. Through follow up with the user facility, us endoscopy learned that the user attempted to withdraw the raptor with grasped stent through the accessory channel of the endoscope. This technique is contrary to the instructions for use, which directs "keeping the object secured in the grasping jaws, withdraw the object together with the endoscope from the patient. Do not retract the device and the object into the endoscope; this could cause damage to the endoscope and the device". The cause of the event is attributed to the user attempting to withdraw the raptor device and retrieved object through the accessory channel of the endoscope, which is contrary to the instructions for use. The procedure was completed using a second raptor device, while withdrawing the stent together with the endoscope, as directed in the instructions for use. 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. In-service training was completed on 11/21/2018; there have been no further issues reported since.
Patient Sequence No: 1, Text Type: N, H10
[131379511]
The user facility reported the jaw component of a raptor grasping device became detached during a procedure to retrieve a plastic stent. The procedure was completed using a second raptor device, with no report of harm to the patient or user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2018-00042 |
| MDR Report Key | 8181566 |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-11-20 |
| Date Mfgr Received | 2018-11-20 |
| Device Manufacturer Date | 2018-08-17 |
| Date Added to Maude | 2018-12-19 |
| 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 | 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 | 2018-12-19 |
| Model Number | 00711177 |
| Catalog Number | 00711177 |
| Lot Number | 1813494 |
| 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 | 2018-12-19 |