MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARD C-MAX CUTTING LOOP; C-MAX CUTTING LOOP ELECTRODE

Catalog Number 355325

Device Problem Break (1069)

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

Event Date 11/20/2015

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the electrode broke during a procedure.

Manufacturer Narrative

Received 1 used c-max cutting loop with the original unit packaging.During visual examination it was noted that the cutting loop was broken in the sample.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The complaint was confirmed with an unknown root cause.The instructions for use state the following: "¿ 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 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.¿ 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." (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.

• Brand Name: BARD C-MAX CUTTING LOOP
• Type of Device: C-MAX CUTTING LOOP ELECTRODE
• 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: 5313616
• MDR Text Key: 34757726
• Report Number: 1018233-2015-00576
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2019
• Device Catalogue Number: 355325
• Device Lot Number: NGZH2732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2016
• 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