MAUDE Adverse Event Report: BOWA-ELECTRONIC GMBH HF CONNECTION CABLE, MONOPOLAR, 3M; MONOPOLAR CABLE

Model Number	8106.033
Medical Device Problem Codes	Break (1069); Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2016
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4) received a medwatch report ((b)(4)) from the fda regarding an incident where a cable broke during use, caught fire and damaged a generator also in use.Cable was unplugged and fire contained with no negative results.Both the cable and the generator were removed and replaced with backup devices.Facility found damaged circuit board in generator.No injury to patient or staff reported.Cable manufacturer has been notification of event, along with cable id and serial number of device.Cable has not been returned for investigation as of 12/19/2106.(b)(4) has contacted user facility for additional information and for the return of cable, no response as of 12/19/2016 manufacturer date: week of 11/30/2015.(b)(4) received date: 12/15/2015.Facility purchased date: 07/07/2016.(b)(4) considers this matter closed.However, in the event (b)(4) receives the device or any additional information, (b)(4) will provide manufacturer with follow-up information/device.(b)(4).

• Brand Name: HF CONNECTION CABLE, MONOPOLAR, 3M
• Common Device Name: MONOPOLAR CABLE
• Manufacturer (Section D): BOWA-ELECTRONIC GMBH; heinrich-hertz-strasse 4-10; gomaringen, 72810 ; GM 72810
• MDR Report Key: 6186391
• Report Number: 1418479-2016-00021
• Device Sequence Number: 1026997
• Product Code: GEI
• UDI-Device Identifier: 04055207000694
• UDI-Public: 04055207000694
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 11/28/2016
• Report Date (Section F): 12/19/2016

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: 8106.033
• Device Lot Number: 549/040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/28/2016
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2016
• 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: GENERATOR
• Patient Age: 59 YR
• Date Report Sent to FDA: 12/19/2016