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

Model Number 355305

Device Problem Intermittent Loss of Power (4016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2022

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 bd represents all the known information at this time.The device was not returned.

Event Description

It was reported that the cutting loop did not slide well in the instrument as it was designed to.There were also concerns that the cutting loop was not cauterizing as well as it should be.This has been happening with different lot numbers as well.Per follow-up information received on 08-feb-2022, customer provided some of the lot numbers with similar issues of cutting loop not sliding well, and similar issues of cutting loop not cauterizing as well as it should.

Manufacturer Narrative

The reported event is inconclusive because no sample was returned.A potential root cause for this event could be, "material not conductive".The device was not returned for evaluation.No manufacturing issues or non-conformances were noted during review of the dhr that could have caused or contributed to the reported event.Based on the results of the investigation no additional action is required at this time.The instructions for use were found adequate and state the following: "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." "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)." the information provided by bd represents all 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 bd.

Event Description

It was reported that the cutting loop did not slide well in the instrument as it was designed to.There were also concerns that the cutting loop was not cauterizing as well as it should be.This has been happening with different lot numbers as well.Per follow-up information received on (b)(6) 2022, customer provided some of the lot numbers with similar issues of cutting loop not sliding well, and similar issues of cutting loop not cauterizing as well as it should.

• 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 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14732930
• MDR Text Key: 301331084
• Report Number: 1018233-2022-04715
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 00801741018541
• UDI-Public: (01)00801741018541
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

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: 05/23/2023
• Device Model Number: 355305
• Device Catalogue Number: 355305
• Device Lot Number: NGEW4491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/17/2022
• Supplement Dates Manufacturer Received: 06/17/2022
• Supplement Dates FDA Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2020
• 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
• Patient Outcome(s): Other