MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PROMAX¿ SERIES BARD® MAX-BLADE¿ COAGULATING RESECTOR; MAX BLADE

Model Number 355205

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2017

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 the user found a foreign material looking like rust on the blade before use.

Manufacturer Narrative

Received 1 coagulating resector in open packaging.The reported event was confirmed.During the visual inspection, brown staining at the tip of the resector was noted.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "information for use device description: the bard max-blade coagulating resector device is a monopolar electrode designed to deliver radio frequency energy that is supplied by an electrosurgical generator cleared for medical use.Indications for use: the bard max-blade coagulating resector device is indicated for resection and coagulation of soft tissue including procedures for the treatment of benign prostatic hypertrophy (bph).It is intended for use with compatible resectoscopes.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 max-blade coagulating resector 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 max-blade coagulating resector 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 max-blade coagulating resector 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 max-blade coagulating resector 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.If a standard resectoscope cutting loop is used after using the bard max-blade coagulating resector device, the electrosurgical power setting must be adjusted to the appropriate level.How supplied and stored: the bard max-blade coagulating resector device is supplied sterile by eto and is designed for single use.Store in a cool, dry place.Sterile unless package is opened or damaged.Directions for use: remove the bard max-blade coagulating resector 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 max-blade coagulating resector device into the working channel of the resectoscope in the same manner as for an existing cutting loop electrode and consistent with the instructions of the resectoscope.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.Bard medical division warrants to the first purchaser of this product that this product will be free from defects in materials and workmanship for a period of one year from the date of first purchase and liability under this limited product warranty will be limited to repair or replacement of the defective product, in bard medical division sole discretion or refunding your net price paid.Wear and tear from normal use or defects resulting from misuse of this product are not covered by this limited warranty." (b)(4).

Event Description

It was reported that the user found a foreign material looking like rust on the blade before use.

• Brand Name: PROMAX¿ SERIES BARD® MAX-BLADE¿ COAGULATING RESECTOR
• Type of Device: MAX BLADE
• 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: 6670690
• MDR Text Key: 78580613
• Report Number: 1018233-2017-03294
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 00801741018459
• UDI-Public: (01)00801741018459
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K962538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 355205
• Device Catalogue Number: 355205
• Device Lot Number: NGZG4167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2015
• 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