MAUDE Adverse Event Report: GE HEALTHCARE AUSTRIA GMBH & CO OG VOLUSON E8 BT21; PULSED DOPPLER ULTRASOUND IMAGE SYS

Lot Number E49178, 275675KR7

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/23/2021

Event Type  Injury  

Event Description

A customer reported performing a transvaginal diagnostic ultrasound on a pregnant patient where an intrauterine pregnancy was confirmed, and they believed a second ectopic pregnancy was also present.Another sonographer was asked to examine the patient transabdominally and both agreed they were unable to reproduce the same findings.The patient was then examined transvaginally once again and the same finding as the first exam was observed.It was also noted that they felt more bowel than usual.These findings were reviewed with a treating clinician who decided to perform a laparoscopic examination.The conclusion of the laparoscopy was that there was no ectopic pregnancy, and a follow-up ultrasound also confirmed there was no ectopic pregnancy.The customer provided gehc exam images for review.Gehc reviewed the images and found there was a mirror image artifact in the transvaginal exams.At this time there is no indication of a system malfunction, and gehc is investigating this issue further.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Gehc has concluded its investigation.Gehc reviewed the case with the customer and was able to obtain exam images from the customer for review & assessment.It was also noted that the customer was looking for gehcâs assistance in determining why they saw what they thought was an ectopic pregnancy trans-vaginally and not transcutaneously.The review & assessment by a gehc medical director and gehc sonographer of the exam images provided determined that the images were of diagnostic quality and the voluson e8 (with the associated probes) is operating normally.What the customer had seen was a mirror-image artifact of the present intrauterine pregnancy.Furthermore, a service engineer evaluated the devices in question and no instances of product-caused image artifacts were found.The cause of the event has been determined to be an ultrasound image artifact inherent to the nature of the physics of ultrasound wave propagation (i.E.Reflecting on anatomical interface inside the patients body, a phenomenon described in medical literature), and it was additionally confirmed there is no product malfunction.In conclusion the residual risk associated with a mirror-image artifact that led the clinician to a false positive conclusion of heterotopic pregnancy, and subsequently led to an unnecessary minimally invasive laparoscopic procedure, is reduced afap and risk mitigations in place remain effective.This event and conclusions were discussed with the customer, and no further action is required at this time.

• Brand Name: VOLUSON E8 BT21
• Type of Device: PULSED DOPPLER ULTRASOUND IMAGE SYS
• Manufacturer (Section D): GE HEALTHCARE AUSTRIA GMBH & CO OG; tiefenbach 15; zipf oberosterreich, 4871 ; AU 4871
• Manufacturer (Section G): GE HEALTHCARE AUSTRIA GMBH & CO OG; tiefenbach 15; zipf oberosterreich, 4871 ; AU 4871
• Manufacturer Contact: joseph tamblyn ; 9900 w innovation dr; mail drop: rp-2130 / b4422; wauwatosa, WI 53226-4856
• MDR Report Key: 13093471
• MDR Text Key: 282815360
• Report Number: 8020021-2021-00001
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: E49178, 275675KR7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female