MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-09 for LINEAR EUS SCOPE manufactured by Cook Medical.
[62551173]
During an eus procedure, the needle was impacted in the channel of the scope at its tip. Unable to be passed out of the scope resulting in blunting of the sharp tip of the needle and subsequent sue of 3 different needles. This event also caused damage to the linear echoendoscope which had to be sent for repair. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066667 |
| MDR Report Key | 6173273 |
| Date Received | 2016-12-09 |
| Date of Report | 2016-12-09 |
| Date of Event | 2016-11-29 |
| Date Added to Maude | 2016-12-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINEAR EUS SCOPE |
| Generic Name | LINEAR EUS SCOPE |
| Product Code | GCQ |
| Date Received | 2016-12-09 |
| Model Number | NA |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL |
| Manufacturer Address | WINSTON-SALEM NC 27105 US 27105 |
| Brand Name | 19G ACCESS NEEDLE |
| Generic Name | 19G ACCESS NEEDLE |
| Product Code | FCG |
| Date Received | 2016-12-09 |
| Model Number | NA |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL |
| Manufacturer Address | WINSTON-SALEM NC 27105 US 27105 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-09 |