MAUDE Adverse Event Report: GE VINGMED ULTRASOUND AS 6TC-RS PROBE; DIAGNOSTIC ULTRASONIC TRANSDUCER

Lot Number 96021

Device Problems Contamination (1120); Material Integrity Problem (2978)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

Ge healthcare¿s investigation is ongoing.A follow up report will be submitted after the investigation has been completed.Patient data not provided due to country privacy laws.Date of event unknown.Initial reporter data not provided due to country privacy laws.Device manufacture date unknown.

Event Description

It was reported that evidence of e.Coli bacteria was found on tee probes at the medical facility.The facility requested information from ge healthcare regarding recommended disinfectants with sufficient potency to kill the e.Coli bacteria.Investigation by ge engineering confirmed that the surface of the probes did not meet specifications and could have harbored pathogens despite proper cleaning procedures.Visual inspection showed minor texture irregularities at the flexible part of the tee probes.At enlarged inspection it showed the surface to be highly roughened.

Manufacturer Narrative

Ge healthcare's investigation has concluded that the probe cleaning technique used by the hospital was the root cause of the surface damage found on the endoscope where bacteria from the lower gi could have accumulated.No device malfunction occurred.To address the issue ge healthcare is reviewing the site disinfection and cleaning process with the hospital.Additionally, the site has also started using civco transducer covers on their tee probes.

• Brand Name: 6TC-RS PROBE
• Type of Device: DIAGNOSTIC ULTRASONIC TRANSDUCER
• Manufacturer (Section D): GE VINGMED ULTRASOUND AS; horten ; NO
• Manufacturer (Section G): GE VINGMED ULTRASOUND AS; strandpromenaden 45; horten N-318 3; NO N-3183
• Manufacturer Contact: james giles ; 3000 n grandview blvd; w450; waukesha, WI 53188
• MDR Report Key: 5141644
• MDR Text Key: 27971407
• Report Number: 9610482-2015-00004
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• PMA/PMN Number: K131514
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Followup
• Report Date: 09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 96021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other