MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM; HYSTEROSCOPIC INSUFFLATOR, PRODUCT CODE

Model Number	AQL-100CBS
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Corresponding scale unit: aql-100pbs, serial number (b)(4).The device was not returned for evaluation yet.The most possible root cause is a defective weighing cell, which might be the result of rough handling of the scale.A follow-up report will be submitted when new information is available.
Event or Problem Description
We have been informed of the following event: "technical support was contacted by (b)(6), territory manager, to report holx owned aquilex system "aquilex is not calculating the deficit correctly.It bounces around and runs negative.Three cases were completed today but all had to be manually counted.No issues with the patients.Date of case was (b)(6) 2021."".
Additional Manufacturer Narrative
The results of the investigation performed indicated that the returned device is working according to specification.The device is in poor condition and the preventive maintenance is overdue.The most possible root cause is an uncalibrated weighing cell, as the result of rough handling of the scale and missed preventive maintenance.
Event or Problem Description
We have been informed of the following event: "technical support was contacted by (b)(6), territory manager, to report holx owned aquilex system "aquilex is not calculating the deficit correctly.It bounces around and runs negative.Three cases were completed today but all had to be manually counted.No issues with the patients.Date of case was (b)(6) 2021".

• Brand Name: AQUILEX FLUID CONTROL SYSTEM
• Common Device Name: HYSTEROSCOPIC INSUFFLATOR, PRODUCT CODE
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 11618235
• Report Number: 3002914049-2021-00005
• Device Sequence Number: 2987474
• Product Code: HIG
• UDI-Device Identifier: 04056702006556
• UDI-Public: 04056702006556
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172040
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2021

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
• Operator of Device: Health Professional
• Device Model Number: AQL-100CBS
• Device Catalogue Number: AQL-100CBS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 07/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1