MAUDE Adverse Event Report: RICHARD WOLF GMBH BIPOLAR CABLE 3M

Model Number	8108.033
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Richard wolf medical instruments corporation (rwmic) was notified by facility that a noise was heard during the procedure.Hand held system was removed from patient, generator was activated and a spark was seen.A back up device was readily available for use with minimal delay to procedure.Procedure completed as scheduled.No injury to patient or staff reported.Hand held system consists of the following: kleppinger; forceps insert (inserted into kleppinger); bipolar cable (connects kleppinger to generator) (suspect device).Additional items part of system: bipolar generator ; power cord, generator; footswitch (connects to generator).Facility has been contacted, via email, in an effort to gather additional/missing for this report.No response received as of 20feb2018.Facility purchased (b)(4) bipolar cables (id # 8108.033, lot #348/665) from april 28, 2014 through august 26, 2014.Device approximately 4 years old.There have been no similar complaints reported in the last five years for this device (id #8108.033).Device has not been returned.If rwmic receives device, it will be sent to manufacturer for investigation.Rwmic considers this report closed.If rwmic receives additional information regarding this incident, a follow up report will be sent to the fda.
Event or Problem Description
Follow up report to provide missing, new, corrected, and changed data.
Additional Manufacturer Narrative
Follow-up report #1 is to provide fda with missing information status and to provide new information, corrected, and changed data.Missing information: user facility was contacted 3 times in an effort to collect patient information, patient outcomes, and device / device pictures.As of 7/18/2018, the user facility has not responded to our requests.Device was not returned for evaluation.Device labeling was reviewed for patient code and device codes, see below: patient code: not applicable, no patient problem was reported.Device code: ifu was reviewed.Ifu includes information for dangers of electric shock.Ifu also includes information for combinations, checks (damaged, brittleness, cracks, worn plugs, etc), application, etc.Rw considers this complaint and mdr closed, follow-up reports will be sent to fda as required.

• Brand Name: BIPOLAR CABLE 3M
• Common Device Name: BIPOLAR CABLE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 7283039
• Report Number: 1418479-2018-00002
• Device Sequence Number: 19145047
• Product Code: GEI
• UDI-Device Identifier: 04055207000793
• UDI-Public: 04055207000793
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K983236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2018
• Report Date (Section F): 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 8108.033
• Device Catalogue Number: 8108.033
• Device Lot Number: 348/665
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/26/2018
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 02/20/2018