MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-15 for UROPASS AS 12/14FR X 54 CM 5/BX 61254BX manufactured by Teleflex Medical Oem.
[151321119]
User facility reported about the three devices and this is for the second device that was noted to be broken out of the package. The device was not returned to the service center for evaluation. The exact cause of the reported event cannot be determined at this time. The instruction manual provides warning and caution statements in an effort to prevent breakage; " do not insert this device without comprehensive knowledge of the indications, techniques, and risks associated with the procedure. Do not insert this device if it has been kinked or damaged prior to use. Replace with undamaged product. Avoid contact with sharp objects as the device can be easily nicked, thereby increasing the potential for breakage.?
Patient Sequence No: 1, Text Type: N, H10
[151321120]
The center was informed that during a therapeutic cystoscopy with retrogrades, laser lithotripsy, and stone removal procedure, the sheath was opened by a registered nurse (rn) and passed to surgical technician and then to the sterile field. After the sheath was inserted into the patient it was noted to be broken. A second sheath was then opened and passed to the sterile field. Upon opening this package, it was noted to be broken directly out of the package. Therefore, a third sheath was opened and passed to the sterile field. It was found to be intact, not broken and therefore inserted into the patient. Once inside the patient, it was observed through camera that the sheath had broken into multiple pieces. The sheath was immediately removed from the patient. The surgeon extracted all visualized fragments able to be extracted from the patient. The procedure was completed without the use of the access sheath. There was no patient injury reported. In addition, the user facility reported that materials management was notified and removed remaining items immediately following the case. This is 2 of 3 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-01008 |
| MDR Report Key | 8789688 |
| Date Received | 2019-07-15 |
| Date of Report | 2019-10-31 |
| Date of Event | 2019-06-18 |
| Date Mfgr Received | 2019-07-30 |
| Date Added to Maude | 2019-07-15 |
| 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 | 3 |
| Brand Name | UROPASS AS 12/14FR X 54 CM 5/BX |
| Generic Name | UROPASS URETERAL ACCESS SHEALTH |
| Product Code | KYN |
| Date Received | 2019-07-15 |
| Returned To Mfg | 2019-07-03 |
| Model Number | 61254BX |
| Lot Number | 09C1500205 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL OEM |
| Manufacturer Address | 3750 ANNAPOLIS LN N, SUITE 160 PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-15 |