MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-21 for FORCEPS, BIPOLAR 8383.21 manufactured by Richard Wolf Medical Instruments Corp..
[22461674]
An investigation could not be completed as the actual device was not returned to the rwmic facility as of 07/21/2015. In addition, several attempts for additional information as well as photos of device in question were requested. No information or photos submitted as of 07/21/2015. No similar issues have occurred on this device in the last ten years. No serial number of device given, unable to determine actual age of device. Based on purchase history device was purchased prior to 2004. (at least 10 years old). Labeling was reviewed and found to be adequate. Ie intended use, indications and field of use, preparation and cautions regarding high temperatures and irrigation fluid. Rwmic considers this matter closed. However, in the event rwmic receives additional information, a follow-up report will be provided to fda.
Patient Sequence No: 1, Text Type: N, H10
[22461675]
Richard wolf medical instrument corp. (rwmic) was notified by facility that a patient was burned sometime during a procedure. Facility used a few different devices during the procedure, the following is the suspect device: jaw insert ((b)(4)). Report (b)(4). The above device work in conjunction with the following devices: bipolar forceps, bipolar cable, generator, foot switch.
Patient Sequence No: 1, Text Type: D, B5
[27617774]
Facility replacing device with new one.
Patient Sequence No: 1, Text Type: N, H10
[27617775]
Upon further investigation, reporting facility is now reporting that during a bilateral tubal ligation, the insert adhered to the tube and did not release and thus a there was a fear insert may have touched or burned the ovary. A thorough exam, done by the surgeon, there was no burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2015-00019 |
| MDR Report Key | 4939884 |
| Date Received | 2015-07-21 |
| Date of Report | 2015-09-09 |
| Date Mfgr Received | 2015-09-09 |
| Date Added to Maude | 2015-07-24 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAWN CLARK |
| 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 |
| Generic Name | FORCEPS |
| Product Code | HIN |
| Date Received | 2015-07-21 |
| Model Number | 8383.21 |
| Catalog Number | 8383.21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2015-07-21 |