MAUDE Adverse Event Report: GE HEALTHCARE GE HEALTHCARE IC5-9-D; GE ENDOCAVITORY PROBES

Model Number IC5-9-D

Device Problem Contamination (1120)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Upon cleaning one of our ge endocavitary probes after a prostate biopsy, blood had collected where the handle meets the probe.It has what looks like a ring or ridge all the way around the probe.After cleaning the probe we inspected it under a magnifying lens and could see pieces of what looks like a seal is missing all round this ring.We took the probe out of service, contacted our radiology department, infection control and the specialty clinic nurse manager.I contacted ge and began the task of getting someone to help me.After speaking to several people and having them tell me this was normal i insisted that they help me resolve this issue.Finally i was sent to our ge service tech (b)(4).With the help of biomed, we sent them pictures taken with a microscope they have down in biomed shop.After ge acknowledged this was an issue they decided to replace our probes.We received two new probes from ge and upon inspection we could see these probes had the same issue.When i notified (b)(4) and again sent him pictures he then came back and said they are going to send two new probes to me and i will look at them and then bring them to you.I got an email from (b)(4) a couple days later that said the two probes sent to him had the same issue.It is important to note that the concern with the seal area was not visible to the naked eye and therefore would go undetected unless there was close inspection using a microscope.Another issue was also identified.A sharp area was noted where the needle guide attaches to the probe.

• Brand Name: GE HEALTHCARE IC5-9-D
• Type of Device: GE ENDOCAVITORY PROBES
• Manufacturer (Section D): GE HEALTHCARE
• MDR Report Key: 6331515
• MDR Text Key: 67602102
• Report Number: MW5067894
• Device Sequence Number: 1
• Product Code: ITX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2017
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IC5-9-D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1