MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-10-23 for UROPASS AS 12/14FR X 24 CM 5/BX 61224BX manufactured by Teleflex Medical Oem.
[90859183]
The device was not returned to olympus for evaluation. Olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event but with no result. The exact cause of the reported event cannot be determined at this time. However, the instruction manual provides users with several warnings to help prevent damage to the ureteral access sheath: warning and caution section pg. 2: 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. Section 4. 0 section 4. 0 inspection pg. 6: do not use the product unless it is in the original, intact packaging. 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. Do not use a damaged product. Section 5. 0 suggested procedure pg. 8: prior to use, separate the dilator and sheath and place into a container of saline or sterile water for approximately 15 seconds to activate the hydrophilic coating. Re-wet as necessary. Advance the dilator/sheath assembly over the guidewire to the desired location. If resistance is encountered, stop! Do not advance against resistance. Damage to the anatomy could result. Once positioned, grasp and squeeze the dilator clip thumb tabs to release the dilator from the sheath funnel and gently withdraw the dilator, while maintaining sheath position. Do not advance the sheath without the dilator in place.
Patient Sequence No: 1, Text Type: N, H10
[90859184]
Olympus was informed that during a therapeutic uroscopy procedure, the tip of the ureteral sheath detached and fell into the patient. It is unknown if the device fragment was retrieved or if the intended procedure was completed. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00694 |
| MDR Report Key | 6970353 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-10-23 |
| Date of Report | 2018-01-26 |
| Date of Event | 2017-10-05 |
| Date Mfgr Received | 2018-01-11 |
| Device Manufacturer Date | 2016-06-06 |
| Date Added to Maude | 2017-10-23 |
| 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 | UROPASS AS 12/14FR X 24 CM 5/BX |
| Generic Name | UROPASS ACCESS SHEATH |
| Product Code | KNY |
| Date Received | 2017-10-23 |
| Returned To Mfg | 2017-11-20 |
| Model Number | 61224BX |
| Catalog Number | 61224BX |
| Lot Number | 09F160053 |
| ID Number | UDI |
| 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 LANE NORTH, SUITE 160 PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-23 |