MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-02 for RESECTOSCOPE-SHEATH 8661.3741 manufactured by Richard Wolf Gmbh.
[27351491]
Facility reported to one of richard wolf medical instruments corporation (rwmic) customer repair specialist that a device arched and damaged the tip of a second device being used during the procedure. The two impacted devices were swapped out to back up devices, readily available for use, and procedure was completed as scheduled. No injury to patient or staff reported. At least six devices are assembled together in order to operated. The two devices which had product problems and their associated mdr's are: 1) sheath (8661. 3741) - mdr1418479-2015-00031 (tip damaged). 2) electrode (8424. 141) - mdr1418479-2015-00032 (device arched).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2015-00031 |
| MDR Report Key | 5123846 |
| Date Received | 2015-10-02 |
| Date of Report | 2015-09-04 |
| Date Facility Aware | 2015-09-04 |
| Report Date | 2015-10-02 |
| Date Reported to FDA | 2015-10-02 |
| Date Reported to Mfgr | 2015-10-02 |
| Date Added to Maude | 2015-10-02 |
| 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 | RESECTOSCOPE-SHEATH |
| Generic Name | SHEATH |
| Product Code | FDC |
| Date Received | 2015-10-02 |
| Returned To Mfg | 2015-09-30 |
| Model Number | 8661.3741 |
| Catalog Number | 8661.3741 |
| Lot Number | 1211303 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 22 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | 32 PFORZHEIMER STREET KNITTLINGEN, 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-02 |