MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-17 for SINGLE USE ASPIRATION NEEDLE NA-U402SX-4019 manufactured by Olympus Respiratory America.
[93390251]
The needle apparatus was returned to olympus for evaluation. The evaluation found the needle tip and other device components missing, and the needle wire cut, which is consistent with the user facility? S reported actions to detach the needle apparatus from the scope. The reported failure to retract was not duplicated due to the damaged device preventing mechanical testing. A potential cause for the reported retraction issue is user technique. The instruction manual contains several cautions and directions to prevent device damage and patient injury, such as? Do not angulate/flex the bending section of the endoscope abruptly while the needle is protruding from the instrument channel of the endoscope.? ? Do not extend the needle from the distal end of the endoscope without first confirming the position of the sheath in the endoscopic field of view/video image? , and? Do not withdraw the needle from the endoscope unless the needle slider is pulled back completely until it clicks; otherwise, the needle could extend abruptly from the sheath? S distal end.? Another potential cause is needle compatibility issues with the bf-uc180f scope used in the procedure. Per the bf-uc180f instruction manual, a different model needle is indicated for use with this scope. The scope instruction manual states that only certain accessories are compatible due to the scope? S unique shaped instrument channel outlet. The scope manual also warns that? Using incompatible equipment can result in patient injury and/or equipment damage.?
Patient Sequence No: 1, Text Type: N, H10
[93390252]
Olympus was informed that during an ebus procedure, while the device was collecting specimen from a lymph node, the needle tip did not retract back into its sheath. The scope with the needle device attached was withdrawn from the patient with the needle still sticking out. The procedure was completed with a different needle. There was no report of patient injury or tissue trauma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00733 |
| MDR Report Key | 7042546 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-17 |
| Date of Report | 2017-11-17 |
| Date of Event | 2017-10-25 |
| Date Mfgr Received | 2017-10-25 |
| Date Added to Maude | 2017-11-17 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINGLE USE ASPIRATION NEEDLE |
| Generic Name | SINGLE USE ASPIRATION NEEDLE |
| Product Code | KTI |
| Date Received | 2017-11-17 |
| Returned To Mfg | 2017-11-06 |
| Model Number | NA-U402SX-4019 |
| Catalog Number | NA-U402SX-4019 |
| Lot Number | W02292-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS RESPIRATORY AMERICA |
| Manufacturer Address | 6675 185TH AVE NE REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-17 |