MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH HYSTEROLUX FLUID MANAGEMENT SYSTEM; PUMP FOR HYSTEROSCOPY, FLUID MONITORING SYSTEM AND TUBE SETS

Model Number	PS304
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
We have been informed of the following event: "according to the reporter, the unit had deficit calculation issues.There was no patient involvement.Additional information 1.How was the issue noticed? during set up.2.Could we please get more information, if there was issue with low deficit or higher deficit? low deficit.As the complaint is regarding the deficit, which could be related to an issue with scale.3.Could you please provide sn of the scale and send back also the scale back as well? rep sent it off.".
Additional Manufacturer Narrative
At the time of the reporting decision the device has not yet been returned for evaluation and the evaluation results were not available.Furthermore, there are no information about the scale.With this limited information the most probable root cause could not be determined.It could be a device-independent issue or an actual malfunction.As per the reporter, the issue was noticed prior to the use (during set up).There was no patient involvement.No patient harm or injury reported.In case of a potential malfunction, we cannot exclude that it could cause or contribute-ute to serious injury if it were to reoccur.If new information is received, or if the device is returned for evaluation, the reporting decision will be re-evaluated accordingly.

• Brand Name: HYSTEROLUX FLUID MANAGEMENT SYSTEM
• Common Device Name: PUMP FOR HYSTEROSCOPY, FLUID MONITORING SYSTEM AND TUBE SETS
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; w.o.m. world of medicine gmbh; salzufer 8; berlin, berlin 10587 ; GM 10587
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; alte poststrase 11; ludwigsstadt, 96337 ; GM 96337
• Manufacturer Contact: sushira panchama ; w.o.m. world of medicine gmbh; salzufer 8; berlin, berlin 10587 ; GM 10587
• MDR Report Key: 20143351
• Report Number: 3002914049-2024-00003
• Device Sequence Number: 7398478
• Product Code: HIG
• UDI-Device Identifier: 04056702006273
• UDI-Public: 04056702006273
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/05/2024

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: PS304
• Device Catalogue Number: PS304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown