MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARD C-MAX CUTTING LOOP .012IN, COMPATIBLE RESECTOSCOPE-STORZ-SINGLE STEM, 27 FR

Catalog Number 355315

Device Problems Break (1069); Detachment Of Device Component (1104)

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

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 product tip allegedly broke off, while inside of the patient during a procedure.The pieces were removed from the prostate, and no injuries were reported.

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 product tip allegedly broke off, while inside of the patient during a procedure.The pieces were removed from the prostate, and no injuries were reported.

Manufacturer Narrative

Received one (1) used c-max cutting loop with the original unit package.During the visual inspection, it was noted that the tip was broken and the broken section was returned with sample.The reported event was confirmed as cause unknown.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: "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." (b)(4).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 product tip allegedly broke off, while inside of the patient during a procedure.The pieces were removed from the prostate, and no injuries were reported.

• Brand Name: BARD C-MAX CUTTING LOOP .012IN, COMPATIBLE RESECTOSCOPE-STORZ-SINGLE STEM, 27 FR
• Type of Device: CUTTING LOOP
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5892507
• MDR Text Key: 52616521
• Report Number: 1018233-2016-01099
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2019
• Device Catalogue Number: 355315
• Device Lot Number: NGZI0513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2015
• 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
• Patient Outcome(s): Required Intervention