WORKING ELEMENT 8680.224

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-22 for WORKING ELEMENT 8680.224 manufactured by Richard Wolf Germany (rwgmbh).

Event Text Entries

[83243782] (b)(4) sales representatives was notified by facility that during a bipolar turbt procedure two nurses were shocked when they grabbed the biz monitor device while removing it from the patient. No injury to patient was reported. Two separate mdrs will be submitted, one for each nurse: mdr 1418479-2017-00018, nurse #1, mdr 1418479-2017-00019, nurse #2. User facility was contacted in an effort to gather additional/missing medwatch information, no response as of 08/22/17. Manufacturer / device returned for investigation: (b)(4) working element (id #8680. 224 lt #1324186); (b)(4) electrode (id #4622. 1313 lt #51007450); (b)(4) bipolar cable (id #8108. 232 lt #07/14); (b)(4) unipolar cable (id #815. 033 lot #128/180). Additional devices used during procedure: (b)(4) generator (id #unknown), biz monitor (id #unknown). Manufactured date: 12-oct-2016, purchase date: (b)(6) 2017, service date: n/a. (b)(4) received actual device from user facility on 03-aug-2017. A visual inspection of device found shaft was bent. No problems found when functional testing was performed on device. (b)(4) could not replicate event with the devices returned for investigation. None of the returned devices contained damage or defects that would have caused nurse to be shocked. Root cause of event is unknown. Two similar event resulting in an mdr has occurred on this device in the last three years (mdr 1418479-2015-00034 & mdr 1418479-2017-00018). (b)(4) considers this matter closed. However, in the event (b)(4) receives additional information, follow-up report will be submitted to fda.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1418479-2017-00019
• MDR Report Key: 6810262
• Date Received: 2017-08-22
• Date of Report: 2017-09-20
• Date of Event: 2017-07-27
• Date Facility Aware: 2017-07-27
• Report Date: 2017-10-02
• Date Reported to FDA: 2017-10-02
• Date Reported to Mfgr: 2017-10-02
• Date Added to Maude: 2017-08-22
• 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
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: WORKING ELEMENT
• Generic Name: WORKING ELEMENT
• Product Code: FDC
• Date Received: 2017-08-22
• Model Number: 8680.224
• Catalog Number: 8680.224
• Lot Number: 1324186
• Operator: PHYSICIAN
• Device Availability: Y
• Device Age: 10 MO
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RICHARD WOLF GERMANY (RWGMBH)
• Manufacturer Address: REGISTRATION NUMBER 9611102 32 PFORZHEIMER STREET KNITTLINGEN, 75438 GM 75438

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2017-08-22