MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-06-27 for WORKING ELEMENT 8653.224 manufactured by Richard Wolf Gmbh.
[4514900]
On (b)(6) 2014, facility contacted richard wolf medical instruments corporation (rwmic) incidating they would like to send in their working element to be checked, routine maintenance. One facility received cost estimate of repairs, facility mentioned an incident where a spark occurred. A few parts on device were replaced due to being loose and/or work out.
Patient Sequence No: 1, Text Type: D, B5
[12146356]
An investigation was completed as the actual device was returned on (b)(4) 2014. A few parts on device were replaced due to being loose and/or worn out. No record of any routine maintenance or repairs. If moisture or liquid were to get in lock hosing, a spark may occur. (i. E. Device not completely dried after reprocessing or from fluids during use due to worn o-ring). Labeling was reviewed and found to be adequate. I. E. , intended use, indications and field of use, preparation and cautions. Richard wolf considers this matter closed. However, in the event we receive additional info, we will provide fda with follow-up info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2014-00032 |
| MDR Report Key | 3912378 |
| Report Source | 99 |
| Date Received | 2014-06-27 |
| Date of Report | 2014-06-10 |
| Date of Event | 2014-05-01 |
| Date Facility Aware | 2014-06-10 |
| Report Date | 2014-06-27 |
| Date Reported to FDA | 2014-06-27 |
| Date Reported to Mfgr | 2014-06-27 |
| Date Added to Maude | 2014-07-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WORKING ELEMENT |
| Generic Name | WORKING ELEMENT |
| Product Code | FDC |
| Date Received | 2014-06-27 |
| Returned To Mfg | 2014-06-03 |
| Model Number | 8653.224 |
| Catalog Number | 8653.224 |
| Lot Number | 1106343 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | KNITTLINGEN 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-06-27 |