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	08/31/2020
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: HYSTEROSCOPIC INSUFFLATOR
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 10611853
• Report Number: 3002914049-2020-00009
• Device Sequence Number: 14104382
• Product Code: HIG
• UDI-Device Identifier: 04056702005672
• UDI-Public: 04056702005672
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: PH304
• Device Catalogue Number: 72205000
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1