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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KRETZ GE HEALTHCARE AUSTRIA GMBH & CO OG VOLUSON P6 W/RIC5-9W-RS PROBE; ULTRASONIC DIAGNOSTIC TRANSDUCER

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KRETZ GE HEALTHCARE AUSTRIA GMBH & CO OG VOLUSON P6 W/RIC5-9W-RS PROBE; ULTRASONIC DIAGNOSTIC TRANSDUCER Back to Search Results
Model Number RIC5-9W-RS PROBE
Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Align (2522); Malposition of Device (2616)
Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Excessive Tear Production (2235)
Event Date 10/20/2016
Event Type  Injury  
Manufacturer Narrative
Patient information could not be obtained due to country privacy laws.Udi not required because this is a class ii device and the date of manufacture is prior to 24-sept2016.Device returned to manufacturer and is currently under evaluation.The date of device manufacture is unavailable at time of mdr filing.Ge healthcare's investigation is ongoing.A follow up report will be submitted after the investigation has been completed.
 
Event Description
It was reported that three patients each were injured on separate dates.This report represents the third patient injury, patient (b)(6).The ric5-9w-rs ultrasound probe, along with a voluson p6, biopsy needle ebt 00230s-0 (elios bio tek), and a biopsy guide of unknown type were being used to assist an ovarian biopsy for harvesting oocytes when the ovary was punctured and/or torn with the biopsy needle.Surgery, celiography, was required in order to stop the internal bleeding.The user reported that the virtual guide for the needle was offset and therefore needle placement was incorrect.
 
Manufacturer Narrative
Updated with manufacture dates.Probe serial # (b)(4), date of manufacture is 13-may2014 and probe serial (b)(4), date of manufacture is 01-apr2015.The probes were replaced to correct this issue, ges investigation has concluded and the results are as follows: both probes had been mechanically damaged (dropped) prior to use, and the 3d scan head could not properly calibrate causing the "virtual guide" to be offset.The user was able to detect the damage via a failed calibration message, and the user decided to continue to operate/use the damaged probes.Therefore the injuries were due to continued use of a damaged & malfunctioning probe despite being warned of the malfunction.Further analysis of malfunction complaint data and design documentation indicates the probability of reoccurrence is remote.
 
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Brand Name
VOLUSON P6 W/RIC5-9W-RS PROBE
Type of Device
ULTRASONIC DIAGNOSTIC TRANSDUCER
Manufacturer (Section D)
KRETZ GE HEALTHCARE AUSTRIA GMBH & CO OG
tiefenbach 15
zipf
AU 
Manufacturer Contact
joseph tamblyn
9900 w. innovation dr.
wauwatosa, WI 
MDR Report Key6156902
MDR Text Key61851742
Report Number8020021-2016-00005
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K122387
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberRIC5-9W-RS PROBE
Device Lot Number175616KR2/190438KR2
Other Device ID NumberUDI NOT REQUIRED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/09/2016
Initial Date FDA Received12/08/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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