MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-04 for RAPTOR GRASPING DEVICE 00711177 manufactured by United States Endoscopy Group, Inc..
[141043489]
The user facility was contacted by us endoscopy but has declined to provide any information regarding the procedure aside from that there was no harm to 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 the event was returned to us endoscopy for evaluation. Examination of the returned device revealed that, contrary to the initial report, no portion of the device appears to have detached during use. The drive wires of the device were bent in a manner which indicates the device damage was due to the application of excessive force by the user. The instructions for use include the following statements: "do not use excessive force on the handle and do not coil the catheter outside of the endoscope. Excessive force or coiling may damage the device... Apply continuous gentle traction while squeezing the slider toward the thumb ring. Do not use excessive force or coil the sheath outside of the endoscope. This may damage the device and render it inoperable. 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. " us endoscopy has offered in-service training on the use of the device. However, the user facility has declined. There have been no further issues reported.
Patient Sequence No: 1, Text Type: N, H10
[141043490]
Reference user facility medwatch report #5084083. The user facility reported that a raptor grasping device broke during a procedure, necessitating retrieval of a portion or portions of the device. There were no injuries associated with the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2019-00015 |
| MDR Report Key | 8484171 |
| Date Received | 2019-04-04 |
| Date of Report | 2019-04-04 |
| Date of Event | 2019-02-09 |
| Date Mfgr Received | 2019-03-08 |
| Device Manufacturer Date | 2018-12-26 |
| Date Added to Maude | 2019-04-04 |
| 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 | 2019-04-04 |
| Model Number | 00711177 |
| Catalog Number | 00711177 |
| Lot Number | 1820710 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-04-04 |