MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH HYSTEROLUX FLUID MANAGEMENT SYSTEM; HYSTEROSCOPIC INSUFFLATOR

Model Number	PS304
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Because of issues with the device, the surgery time was prolonged, and the patient received approximately 350 ml more irrigation fluid than is recommended by the aagl guideline (2000), leading to an extended 2-night stay hospitalization.It remains unknown whether the patient received medication to relieve or prevent oedema.Although no further information on the event or treatment of the patient was received, wom decided to classify the report as serious injury.The device was returned to the manufacturer in poor condition (bent pump try holder, scratched and chipped irrigation fluid bag holder, scratched tray handle, and chipped the wheelbase).First evaluation of the device confirmed the described error pattern, and at present an issue with the circuit board is expected to be the root cause.The scale was subjected to mechanical forces (likely customer misconduct) so that the pump tray holder was bent.It might be possible that the harsh treatment that led to this damage also had an effect on further scale parts including the circuit board.Furthermore, a mechanical incorrect load may have damaged the board.Device evaluation is ongoing to understand whether customer misconduct or a device internal problem is the cause of the event.A follow up report will be filed when more information becomes available.
Event or Problem Description
We have been informed of the following event: "according to the reporter, during a hysteroscopy, the machine was working normally and then switched to diagnostic mode in the middle of the case.Since there were no alarms of high deficit, the unit kept going and they noticed by doing manual count (b)(4) was missing and presumed to be inside the body.After rebooting the machine many times, the unit would work and moved to diagnostic mode and then they would get a scales defective saying.The scale test was still 0.The surgical time extended 30 minutes and procedure was aborted.The (b)(4) fluid was not removed and was absorbed to the blood stream.The patient had an extended 2-night stay hospitalization and was doing well.".
Additional Manufacturer Narrative
The manufacturer did not receive further data on the patient.The manufacturer conducted further research on the device.First evaluation of the device had confirmed the described error pattern, and an issue with the circuit board was expected to be the root cause.After exchange of both load cells and the scale circuit board, the device was functioning according to specification and issued warning messages in case of loss of scale connection as specified.The scale had been subjected to mechanical forces (likely customer misconduct) so that the pump tray holder was bent.It might be possible that the harsh treatment that led to this damage also had an effect on further scale parts including the circuit board.
Event or Problem Description
We have been informed of the following event: "according to the reporter, during a hysteroscopy, the machine was working normally and then switched to diagnostic mode in the middle of the case.Since there were no alarms of high deficit, the unit kept going and they noticed by doing manual count 2850 was missing and presumed to be inside the body.After rebooting the machine many times, the unit would work and moved to diagnostic mode and then they would get a scales defective saying.The scale test was still 0.The surgical time extended 30 minutes and procedure was aborted.The 2850 fluid was not removed and was absorbed to the blood stream.The patient had an extended 2-night stay hospitalization and was doing well.".

• Brand Name: HYSTEROLUX FLUID MANAGEMENT SYSTEM
• Common Device Name: HYSTEROSCOPIC INSUFFLATOR
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin 10587 ; GM 10587
• MDR Report Key: 10095937
• Report Number: 3002914049-2020-00005
• Device Sequence Number: 3406816
• Product Code: HIG
• UDI-Device Identifier: 04056702006273
• UDI-Public: 04056702006273
• Combination Product (Y/N): N
• PMA/510(K) Number: K173489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PS304
• Device Catalogue Number: 72205001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2020
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization