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

Model Number 355301

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that prior to use, the cutting loop broke.

Manufacturer Narrative

The reported issue was confirmed.The device was returned, with its package opened for evaluation.Visual evaluation noted a break on the side of the cutting loop.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿potential complications: complications could include local and/or systemic infection, thermal damage to surrounding structures, local hematoma, dissection and perforation, distal tip separation, and patient discomfort during and/or after energy application.Precautions: all medical staff should carefully review product labeling and instruction sheets before using the bard c-max cutting loop device.Inappropriate use of the instrument could adversely affect the procedure or cause injury to the patient.Refer to the applicable operating and maintenance manuals for the resectoscope and electrosurgical generator being used.The bard c-max cutting loop device should be used only by a physician who is familiar with the use of electrosurgical instruments, devices and power generators.Consult the medical literature regarding techniques, typical power settings, complications, and hazards prior to any endoscopic procedure.During application of electrical energy, movement of the tip is required to achieve the desired tissue effect.The time and energy required for treating specific tissue may differ when using the bard c-max cutting loop device compared to other electrosurgical devices.The monopolar electrosurgical generator should be set to the cut or pure cut mode for maximum tissue removal effect.Do not use the blend mode and be cautious of arcing on high coagulation power settings.Starting at power settings consistent with standard resectoscope cutting loop procedures, gradually increase power until the desired tissue effect is achieved.If there is little or no tissue effect, check the generator, power and grounding cables and the electrodes.Various electrosurgical generators have different power delivery capabilities.Depending on the impedance in the monopolar circuit, the power delivered may be lower than the power setting indicates (see owner/operator manual for the generator being used).Constant irrigation is required throughout the procedure, and the distal tip of the device should be submerged and kept in view at all times.Use sterile non-conductive irrigation solution only.Immediately discontinue use if breaks or fractures appear in the bard c-max cutting loop device.Breaks or fractures may allow undirected emission of electrical energy, rendering the device useless and potentially causing harm to surrounding tissues.Do not bend or manipulate the device.Care should be taken to avoid severe impacts, side stresses or bends at sharp angles.When endoscopic devices are used together, ensure that any isolation or ground is not violated.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.The power level can be adjusted and varied slightly for different patients and also when tissue is being removed on subsequent sweeps.The level of effect is governed by the amount of time the electrode is in contact with an area and the power delivered.The slower the electrode is moved across any particular area and the higher the power applied, the deeper the level of effect.Maintain constant irrigation through the resectoscope using sterile non-conductive irrigant.Keep the tip in the field of view and submerged in irrigant at all times.If tissue adheres to the tip, cleaning can be accomplished by switching to a coagulation setting and engaging current without tissue contact and with tip fully submerged in irrigation solution.Cleaning can also be accomplished by removing the device and wiping it with a soft, sterile lint-free cloth.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations." (b)(4).

Event Description

It was reported that prior to use, the cutting loop broke.

• 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: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6749111
• MDR Text Key: 81367598
• Report Number: 1018233-2017-04005
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 00801741018510
• UDI-Public: (01)00801741018510
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2020
• Device Model Number: 355301
• Device Catalogue Number: 355301
• Device Lot Number: NGAU3890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2017
• Initial Date FDA Received: 07/27/2017
• Supplement Dates Manufacturer Received: 11/15/2017
• Supplement Dates FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2016
• 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