MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-24 for UROPASS AS 12/14FR X 38 CM 5/BX 61238BX manufactured by Teleflex Medical Oem.
[135371973]
The device has not been returned to olympus for evaluation. The cause of the reported complaint cannot be confirmed. To prevent device breakage and injury to the patient, the device instructions for use document 08021 rev. Be warns? Do not insert this device if it has been kinked or damaged prior to use? Replace with undamaged product?. Also,? Avoid contact with sharp objects as the device can be easily nicked?. The document also warns not to advance the device if resistance is felt or the dilator is missing. The placement of the dilator/sheath assembly must also be confirmed via fluoroscopy. The instructions for use document also has pre-procedure inspection instructions:? Inspect the device for any evidence of kinks, nicks, tears, or cracks that might have occurred in the delivery of the device to the sterile field.?
Patient Sequence No: 1, Text Type: N, H10
[135371974]
Olympus was informed that towards the end of an unknown procedure, an approximately 2 centimeter fragment from the tip of the device broke off in the patient as the device was being removed from the patient. The broken off tip was successfully removed from the patient using a semi-rigid wolf 3fr flexible grasper. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00392 |
| MDR Report Key | 8276710 |
| Date Received | 2019-01-24 |
| Date of Report | 2019-03-13 |
| Date Mfgr Received | 2019-03-13 |
| Date Added to Maude | 2019-01-24 |
| 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 | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UROPASS AS 12/14FR X 38 CM 5/BX |
| Generic Name | ACCESSORIES, CATHETER, G-U |
| Product Code | KNY |
| Date Received | 2019-01-24 |
| Model Number | 61238BX |
| Lot Number | 09G1400007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL OEM |
| Manufacturer Address | 3750 ANNAPOLIS LANE NORTH, SUITE 160 PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-24 |