MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-04 for SHEATH, RESECTOSCOPE, PROFILE 8655.384 manufactured by Richard Wolf Germany (gmbh).
[25057743]
Facility notified a (b)(4) sales representative that during a procedure the ceramic tip of the device broke and landed inside of patient. Doctor was able to easily retrieve foreign object and completed procedure as scheduled with readily available backup device. No injury to patient or staff reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2015-00029 |
| MDR Report Key | 5057752 |
| Date Received | 2015-09-04 |
| Date of Report | 2015-08-13 |
| Date of Event | 2015-08-12 |
| Date Facility Aware | 2015-08-13 |
| Report Date | 2015-09-04 |
| Date Reported to FDA | 2015-09-04 |
| Date Reported to Mfgr | 2015-09-04 |
| Date Added to Maude | 2015-09-04 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHEATH, RESECTOSCOPE, PROFILE |
| Generic Name | SHEATH |
| Product Code | FDC |
| Date Received | 2015-09-04 |
| Model Number | 8655.384 |
| Catalog Number | 8655.384 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 8 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GERMANY (GMBH) |
| Manufacturer Address | 32 PFORZHEIMER STREET KNITTLINGEN, 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-04 |