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

Model Number PH304

Device Problem Incorrect Measurement (1383)

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

Event Date 08/31/2020

Event Type  malfunction  

Event Description

We have been informed of the following event: "event description: according to the reporter, during a hysteroscopic myomectomy, while resecting the myoma, the unit's fluid outflow count stopped at 32,540 and when it stopped counting outflow, the deficit began to subtract from 1500.The surgeon was informed, and the staff did a manual count to ensure accurate deficit was still 1500 cc.There was no patient injury." "fluid outflow count stopped at 32540 and once it stopped count-ing outflow, the deficit began to subtract from 1500.Surgeon was informed and staff did a manual count to ensure accurate deficit was still 1500ccs.Hysterolux machine functioned perfectly until it stopped counting outflow at 32540.Then deficit began to subtract.".

• 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: 10611853
• MDR Text Key: 227010706
• Report Number: 3002914049-2020-00009
• 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: 10/01/2020

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: 09/03/2020
• 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