MAUDE Adverse Event Report: KIMBERLY-CLARK HEALTH CARE RADIOFREQUENCY PROBE - CURVED

Catalog Number PMP-20-145C

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2013

Event Type  malfunction  

Event Description

Kimberly-clark received a report stating, "this probe is not working properly, during a rf procedure, the probe causes error windows on the pmg and physician was not able to complete procedure." the procedure was aborted.There is no indication of injury nor the need for medical intervention.(b)(4).

Manufacturer Narrative

The review of the device history record is pending.If any additional relevant information is identified following completion of the dhr review, the additional relevant information will be submitted in a follow-up report.The device was not returned to kimberly-clark for analysis, therefore we are unable to determine a root cause for this reported event.Information from this incident will be included in our product complaint and mdr trend reporting systems.Ongoing analysis of trend information is used to identify the need for additional investigations.

• Brand Name: RADIOFREQUENCY PROBE - CURVED
• Type of Device: RADIOFREQUENCY PROBE
• Manufacturer (Section D): KIMBERLY-CLARK HEALTH CARE; 1400 holcomb bridge rd; bldg 200; roswell GA 30076
• Manufacturer (Section G): BAYLIS MEDICAL CANADA; 5959 trans-canada highway; saint lucent H4T 1A1; CA H4T 1A1
• Manufacturer Contact: ra/qa ae coordinator ; 1400 holcomb bridge rd; bldg 200; roswell, GA 30076 ; 7705877200
• MDR Report Key: 3556230
• MDR Text Key: 4100253
• Report Number: 1033422-2014-00001
• Device Sequence Number: 1
• Product Code: GXD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/10/2013

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: Physician
• Device Catalogue Number: PMP-20-145C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2013
• Initial Date FDA Received: 01/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1