MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-07-25 for FORCEPS, BIPOLAR, KLEPPINGER 8384.240 manufactured by Richard Wolf Medical Instruments Corp..
[4748162]
Customer originally notified richard wolf medical instruments corp (rwmic) to report the generator would only perform at the maximum level, not at the minimum level. After device was received, a follow up call regarding replacement of device was done. At that time, additional information was reported, system caused a burn. The devices below combine to make one system, and these were the devices being used during the procedure, they consist of the following: generator (2352. 011) report 1418479-2014-00036, forceps (8384. 240) report 1418479-2014-00037, jaw insert (8394. 714) report 1418479-2014-00038, footswitch (2030. 103), report 1418479-2014-00039.
Patient Sequence No: 1, Text Type: D, B5
[12220228]
An investigation was completed on 06/30/2014 as the actual device was returned to the rwmic facility. Shaft was bent. Device on its own is not capable of producing enough energy to cause a burn. Device history: no record of any repairs or routine maintenance of device. No similar issues reported in last three years although many devices have been returned to be repaired due to being bent. Root cause due to handling by user. Richard wolf considers this matter closed. However, in the event we receive additional information, we will provide fda with follow-up information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2014-00037 |
| MDR Report Key | 3981339 |
| Report Source | 06 |
| Date Received | 2014-07-25 |
| Date of Report | 2014-06-26 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2014-08-06 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAWN BLARK |
| Manufacturer Street | 353 CORPORATE WOODS PKWY. |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479558016 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORCEPS, BIPOLAR, KLEPPINGER |
| Generic Name | FORCEPS |
| Product Code | HIN |
| Date Received | 2014-07-25 |
| Model Number | 8384.240 |
| Catalog Number | 8384.240 |
| Lot Number | 94Y08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Manufacturer Address | 353 CORPORATE WOODS PKWY. VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-07-25 |