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

Model Number	PH304
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the pump nor the corresponding scale (type ps304, ref 72205001) were returned, nor were the affected serial numbers communicated to date.It remains unknown, whether customer misconduct or a device internal problem is the cause of the potential malfunction.A follow-up report will be submitted when new information is available.
Event or Problem Description
We have been informed of the following event: "according to the reporter, during hysteroscopic myomectomy - removal of fibroid, the deficit was climbing per usual.When changed a bag, the unit signified bag change and the deficit went from +600ml to -900ml.Manually track and count the deficit to ensure no fluid overload issued would occur.There was no patient injury.".

• 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: 11618247
• Report Number: 3002914049-2021-00003
• Device Sequence Number: 11509987
• Product Code: HIG
• UDI-Device Identifier: 04056702005672
• UDI-Public: 04056702005672
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PH304
• Device Catalogue Number: 72205000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1