MAUDE Adverse Event Report: RICHARD WOLF GERMANY (RWGMBH) WORKING ELEMENT

Model Number	8680.224
Health Effect - Clinical Code	Shock (2072)
Date of Event	07/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
(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.One similar event resulting in an mdr has occurred on this device in the last three years (mdr 1418479-2015-00034).(b)(4) considers this matter closed.However, in the event (b)(4) receives additional information, follow-up report will be submitted to fda.

• Brand Name: WORKING ELEMENT
• Common Device Name: WORKING ELEMENT
• Manufacturer (Section D): RICHARD WOLF GERMANY (RWGMBH); registration number 9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 6810257
• Report Number: 1418479-2017-00018
• Device Sequence Number: 19272533
• Product Code: FDC
• UDI-Device Identifier: 04055207042946
• UDI-Public: 04055207042946
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/27/2017
• Report Date (Section F): 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Physician
• Device Model Number: 8680.224
• Device Catalogue Number: 8680.224
• Device Lot Number: 1324186
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/27/2017
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4) UNIPOLAR CABLE; (B)(4) BIPOLAR CABLE; (B)(4) ELECTRODE; (B)(4) GENERATOR; BIZ MONITOR
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 08/22/2017