MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99,unknown report with the FDA on 2014-09-19 for WORKING ELEMENT 8792.636 manufactured by Richard Wolf Gmbh.
[21448043]
Sales rep from richard wolf medical instrument corporation (rwmic) was visiting facility and was told about an incident that occurred during a procedure. The grasping claws on device broke and half of claws fell into pt. The piece was unable to be retrieved. In order to complete the procedure, a backup device was used. No consequences to pt or staff has been reported.
Patient Sequence No: 1, Text Type: D, B5
[21689078]
An investigation has not been completed as the actual device was not returned to rwmic as of (b)(4) 2014. Device is currently in transit to rwmic. Richard wolf considers this matter opened. Device is currently in transit to rwmic for investigation. Once the device is received and add'l info is available, a f/u report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[58726647]
This is a follow up report to change status of this report from open to closed, no new information added. If any additional information is received it will be forwarded to manufacture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2014-00043 |
| MDR Report Key | 4136407 |
| Report Source | 99,UNKNOWN |
| Date Received | 2014-09-19 |
| Date of Report | 2014-08-22 |
| Date of Event | 2014-08-01 |
| Date Facility Aware | 2014-08-22 |
| Report Date | 2014-09-19 |
| Date Reported to FDA | 2014-09-19 |
| Date Reported to Mfgr | 2014-09-19 |
| Date Added to Maude | 2014-10-03 |
| 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 |
| Manufacturer Street | 353 CORPORATE WOODS PKWY. |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Manufacturer Street | 353 CORPORATE WOODS PKWY. |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WORKING ELEMENT |
| Generic Name | WORKING ELEMENT |
| Product Code | FDC |
| Date Received | 2014-09-19 |
| Model Number | 8792.636 |
| Catalog Number | 8792.636 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 9 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STRASSE 32 GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-19 |