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

Model Number PH304

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2021

Event Type  malfunction  

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 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
• Type of Device: HYSTEROSCOPIC INSUFFLATOR
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; alte poststrasse 11; ludwigsstadt, 96337 ; GM 96337
• Manufacturer Contact: lucia puettmann ; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 11618247
• MDR Text Key: 246424574
• Report Number: 3002914049-2021-00003
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04056702005672
• UDI-Public: 04056702005672
• Combination Product (y/n): N
• PMA/PMN Number: K173489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: PH304
• Device Catalogue Number: 72205000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2021
• Initial Date FDA Received: 04/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1