MAUDE Adverse Event Report: GE HEALTHCARE JAPAN CORPORATION; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number IC5-9-D

Device Problems Material Separation (1562); Component Missing (2306); Device Contamination with Body Fluid (2317); Scratched Material (3020)

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

Event Date 02/06/2017

Event Type  malfunction  

Event Description

It was noticed during cleaning that a transducer after a prostate biopsy that blood had collected where the handle meets the transducer, it has what looks like a ring or ridge all the way around the device.After cleaning the transducer 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 device out of service, contacted our radiology department, infection control and the specialty clinic nurse manager.Ge was contacted.Pictures were taken with a microscope and sent to ge, which ge acknowledged this was an issue and replaced the devices.Two new transducers from ge were received and upon inspection these devices had the same issue.Ge was again notified and pictures sent.Ge confirmed that another two new transducers will be sent.These devices also 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.It was also noted that the transducer had a sharp area where the needle guide attached to the probe.As a result of this initial facility report, (b)(6) action was taken to remove these transducers from service to prevent the potential for patient harm.The investigation is ongoing, but initial findings have identified approximately (b)(4) devices with seal separation and (b)(4) had debris identified in the gap.The seal separation provides a space for bioburden to remain, possibly even after reprocessing, which poses a serious public health risk.

• Brand Name: NA
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): GE HEALTHCARE JAPAN CORPORATION; 9900 w. innovation drive; rp-2138; wawatosa WI 53226
• MDR Report Key: 6338625
• MDR Text Key: 67671337
• Report Number: 6338625
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IC5-9-D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/15/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1