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

Model Number PH304

Device Problem Application Program Problem (2880)

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

Event Date 08/25/2020

Event Type  malfunction  

Event Description

We have been informed of the following event: "i was in a myomectomy case that was taking quite a long time.We had been resecting for about an hour and i was keeping a close watch on the deficit and the total volume used.Then all of a sudden, the deficit started dropping from about 1300ml all the way down to 0.And the total inflow volume used froze at 32,450 ml even though the pump was still running and fluid was being used.I watched the machine for a second and the deficit froze at 0ml and the total inflow remained frozen at 32,450ml.No 'scale malfunctions' alerts came on the screen.Everything appeared to be fine, except the ability for the pump to calculate the fluid and the deficit.However we were working for over an hour and had changed bags and canisters over a dozen times.We did a manual deficit count, and deficit was well under the maximum recommended amount however, we decided to abort the procedure for patient safety concerns, seeing as the machine could no longer calculate the deficit.The hysterolux fluid management pump worked properly calculating deficit and total inflow volume used correctly for over an hour of the case, than after about an hour of resection the deficit went from about 1400ml down to 1200 down to 1100, 1000, 800, 600 and all the way down to 0.The deficit reversed from 1400ml to 0.The total inflow volume used froze at 32,450ml at about the same time the deficit stopped at 0, although the pump was running and fluid was coming out.We stopped the procedure, did a manual fluid deficit count (which was about 1600ml) and aborted the procedure.Patient was fine, no injury sustained.".

• 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: 10611535
• MDR Text Key: 231800614
• Report Number: 3002914049-2020-00008
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04056702005672
• UDI-Public: 04056702005672
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/30/2020

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
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1