MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PROMAX¿ SERIES BARD® C-MAX¿ CUTTING LOOP

Model Number	355304
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the electrodes were smoking and burnt the cable.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿directions for use: remove the bard® c-max¿ cutting loop device from the package and examine it for damage.Do not use if there are visible signs of damage or insulation is not intact.Assemble the working element and resectoscope according to the instructions provided by the resectoscope manufacturer.Insert the bard® c-max¿ cutting loop device into the working channel of the resectoscope per instructions indicated in the resectoscope operating manual.Ensure that the electrode is securely placed and locked into position by pulling carefully on the electrode stabilizer sleeve (if appropriate).Attach resectoscope to the electrosurgical generator according to manufacturer's recommendations.Insert the combined assembly into the resectoscope sheath and position at the point where initial application of electrical energy will be delivered.Unless recommended by other sources, the electrosurgical generator should be set on the pure cut setting at power levels consistent with standard resectoscope cutting loop procedures.".
Event or Problem Description
It was reported that the electrodes were smoking and burnt the cable.

• Brand Name: PROMAX¿ SERIES BARD® C-MAX¿ CUTTING LOOP
• Common Device Name: CUTTING LOOP
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8033295
• Report Number: 1018233-2018-05159
• Device Sequence Number: 16518859
• Product Code: FAS
• UDI-Device Identifier: 00801741018534
• UDI-Public: (01)00801741018534
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 355304
• Device Catalogue Number: 355304
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1