MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-02-07 for FLEXIBLE FIBER-URETHRO-CYSTOSCOPE 7305.001 manufactured by Richard Wolf Gmbh (germany).
[66769369]
Device has not been returned as of 02/07/2017. An rma number was issued to the customer and the investigation will follow. A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[66769370]
A piece of the scope fell off and into the patient during a procedure. Rwmic contact the facility, a summary of the event is as follows: the scope came down from the procedure tagged by the surgeon, dr. (b)(6), noting that a piece fell off from the scope during the procedure and was retrieved from the patient with use of a rigid scope. No patient injury. Some delay in the procedure in order to retrieve the scope piece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2017-00002 |
| MDR Report Key | 6308281 |
| Report Source | USER FACILITY |
| Date Received | 2017-02-07 |
| Date of Report | 2017-02-03 |
| Date of Event | 2017-01-30 |
| Report Date | 2018-01-04 |
| Date Reported to FDA | 2018-01-04 |
| Date Reported to Mfgr | 2018-01-04 |
| Date Mfgr Received | 2017-02-03 |
| Date Added to Maude | 2017-02-07 |
| 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. JOZSEF RADOVITS |
| Manufacturer Street | 353 CORPORATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 600613110 |
| Manufacturer Country | US |
| Manufacturer Postal | 600613110 |
| Manufacturer Phone | 8479131113 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXIBLE FIBER-URETHRO-CYSTOSCOPE |
| Generic Name | URETHRO-CYSTOSCOPE |
| Product Code | FBO |
| Date Received | 2017-02-07 |
| Model Number | 7305.001 |
| Catalog Number | 7305.001 |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH (GERMANY) |
| Manufacturer Address | REGISTRATION NUMBER 9611102 32 PFORZHEIMER STREET KNITTLINGEN, 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-07 |