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

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); Injury (2348)

Event Date 11/09/2016

Event Type  Injury  

Manufacturer Narrative

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 first patient injury, patient a.The ric5-9w-rs ultrasound probe, along with a voluson p6, biopsy needle ebt 00230s-0 ((b)(4)), 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.

• 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 Key: 6156898
• MDR Text Key: 61853445
• Report Number: 8020021-2016-00003
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122387
• Number of Events Reported: 1
• 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

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RIC5-9W-RS PROBE
• Device Lot Number: 175616KR2/190438KR2
• Other Device ID Number: UDI NOT REQUIRED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other