MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2017-08-15 for UROPASS AS 12/14FR X 24 CM 5/BX 61224BX manufactured by Teleflex Medical Oem.
[82765826]
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. If additional information or if the device is returned at a later time, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[82765827]
Olympus received a medwatch (mw5070955) report that indicates the tip of the access sheath (a white plastic) was noted to be broken in half after a cystoscopy procedure. It was reported that as surgeon was placing the device fragments together, the plastic was deteriorating in his hand. All of the device fragments appeared to be present. In addition, the surgeon completely washed out the patient? S bladder after incident. It is unknown if the intended procedure was completed. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00535 |
| MDR Report Key | 6795994 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2017-08-15 |
| Date of Report | 2017-08-15 |
| Date of Event | 2016-11-01 |
| Date Mfgr Received | 2017-07-27 |
| Date Added to Maude | 2017-08-15 |
| 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 | 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 | 2017-08-15 |
| Model Number | 61224BX |
| Catalog Number | 61224BX |
| Lot Number | 09HL20009 |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-08-15 |