MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-07 for INNER SHEATH RESECTOSCOPE 86770155 manufactured by Richard Wolf Gmbh.
[119660747]
Rwmic will also gather information from the manufacturer and will attempt to gather additional information from the user facility. A follow up report will be submitted when such information becomes available as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[119660748]
Richard wolf medical instruments corporation, hereinafter referred to as rwmic was notified of an event that occurred during patient use at the user facility. Date of occurrence was not specified. The customer reported that shavings from the inner sheath of the ceramic tip flaked off inside a patient's bladder. The pieces were removed from the patient and there was no adverse outcome to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2018-00018 |
| MDR Report Key | 7855453 |
| Date Received | 2018-09-07 |
| Date of Report | 2018-08-24 |
| Date Facility Aware | 2018-11-06 |
| Report Date | 2018-12-17 |
| Date Reported to FDA | 2018-12-17 |
| Date Reported to Mfgr | 2018-12-17 |
| Date Mfgr Received | 2018-10-01 |
| Device Manufacturer Date | 2012-12-13 |
| Date Added to Maude | 2018-09-07 |
| 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. OLIVER EHRLICH |
| Manufacturer Street | PFORZHEIMER STREET 32 |
| Manufacturer City | KNITTLINGEN, GM 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal | 75438 |
| Manufacturer G1 | RICHARD WOLF GMBH |
| Manufacturer Street | PFORZHEIMER STREET 32 |
| Manufacturer City | KNITTLINGEN, GM 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 75438 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INNER SHEATH RESECTOSCOPE |
| Generic Name | INNER SHEATH RESECTOSCOPE |
| Product Code | FDC |
| Date Received | 2018-09-07 |
| Model Number | 86770155 |
| Catalog Number | 86770155 |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STREET 32 KNITTLINGEN, GM 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-07 |