MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-24 for UROPASS AS 12/14FR X 54 CM 5/BX 61254BX manufactured by Teleflex Medical Oem.
[81277211]
The 09c1500205 sheath tip broken. It was reported that on the incident date? A patient was undergoing ureterorenoscopy. During the operation, a 3mm tip of the ureteral access sheath was found missing after use?. According to the user, no broken part was retrieved/found from the patient body. However, as the missing part was not returned we check with the user about that and the user could not find the missing part. They are not sure whether the part of the access sheath was already lost before using it in the patient. We did not receive patient injury information form the user
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003790304-2017-00001 |
| MDR Report Key | 6735340 |
| Date Received | 2017-07-24 |
| Date of Report | 2017-10-20 |
| Date of Event | 2016-12-06 |
| Date Mfgr Received | 2017-10-16 |
| Date Added to Maude | 2017-07-24 |
| 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 | MR TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 508804-273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UROPASS AS 12/14FR X 54 CM 5/BX |
| Product Code | KNY |
| Date Received | 2017-07-24 |
| Model Number | 61254BX |
| Lot Number | 09C1500205 |
| ID Number | UDI |
| 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 | 2017-07-24 |