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

Model Number 355314

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2018

Event Type  malfunction  

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 Description

It was reported that the electrodes were smoking and burnt the cable.

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 Description

It was reported that the electrodes were smoking and burnt the cable.

• Brand Name: PROMAX¿ SERIES BARD® C-MAX¿ CUTTING LOOP
• Type of Device: CUTTING LOOP
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 8033177
• MDR Text Key: 126074141
• Report Number: 1018233-2018-05155
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 00801741018572
• UDI-Public: (01)00801741018572
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 355314
• Device Catalogue Number: 355314
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/10/2018
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 01/18/2019
• Supplement Dates FDA Received: 02/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1