MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-25 for JAW INSERT, BIPOLAR, ? 5 MM 8394.714 manufactured by Richard Wolf Medical Instruments Corp (rwmic).
[58815469]
An investigation was completed as the actual device was returned to the (b)(4) facility on 09/30/2016. In addition, the handle and bipolar cable being used were also submitted for evaluation. Handle was found to have a slight bend. No other issues with this device. The forceps insert had an electrical short. Electricity most likely traveled from the insert, down the metal handle and to the thumbring where it was making contact with patient's moist skin and caused the burn. No similar events have occurred on this device in the last three years. (b)(4) considers this matter closed. However, in the event (b)(4) receives additional information, a follow-up report will be provided to fda.
Patient Sequence No: 1, Text Type: N, H10
[58815470]
(b)(6) was recently contact by facility to report a patient received a second degree burn. Prior to the initiation of laparoscopic tubal ligation procedure, device system was lying on patients' abdomen when nurse heard the cautery machine being activate and immediately removed cable from power supply. When device was lifted from patients' abdomen a 1 centimeter second burn was found under thumbring of handle. Forceps insert purchased 12/04/2006, approximately 10 years old. No repair or routine maintenance performed at (b)(4) since purchase. Handle purchased 08/04/2005, approximately 11 years old. Handle repaired on 11/10/2005 and 04/14/2010. Kleppinger system made up of the following: handle id #8384. 210 (mdr #1418479-2016-00017); forceps insert id #8394. 714 (mdr #1418479-2016-00020); bipolar cable id #unknown (non (b)(4) device).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2016-00020 |
| MDR Report Key | 6054764 |
| Date Received | 2016-10-25 |
| Date of Report | 2016-09-27 |
| Date of Event | 2016-09-26 |
| Date Mfgr Received | 2016-09-27 |
| Device Manufacturer Date | 2006-10-01 |
| Date Added to Maude | 2016-10-25 |
| 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 | MS DAWN CLARK |
| Manufacturer Street | 353 CORPORTATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 600613110 |
| Manufacturer Country | US |
| Manufacturer Postal | 600613110 |
| Manufacturer Phone | 8003239653 |
| Manufacturer G1 | RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) |
| Manufacturer Street | 353 CORPORATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 600613110 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600613110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | JAW INSERT, BIPOLAR, ? 5 MM |
| Generic Name | GRASPER INSERT |
| Product Code | HIN |
| Date Received | 2016-10-25 |
| Returned To Mfg | 2016-09-30 |
| Model Number | 8394.714 |
| Catalog Number | 8394.714 |
| Lot Number | 249O06 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) |
| Manufacturer Address | 353 CORPORATE WOODS PARKWAY VERNON HILLS IL 600613110 US 600613110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-25 |