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

Model Number	AQL-100CBS
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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: "(b)(6), territory manager, reports that the scale is not working on a new aquilex system.The deficit jumps wildly, and when testing the system (b)(6) reported the deficit was 800ml after dispensing 800ml of fluid.Replacing c&s.Rep was present.No patient impact reported.Awareness/procedure date (b)(6) 2021".
Additional Manufacturer Narrative
The results of the investigation performed indicated that the returned aquilex cart/scale, catalog#aql-100cbs, sn (b)(6) failed due to the calibration data on the scale were incorrect.Calibration of the scale was found to be incorrect leading to a higher deficit displayed.The most probable root cause is seen that the eeprom for the calibration data was found to be defective.
Event or Problem Description
We have been informed of the following event: "dayna pammer, territory manager, reports that the scale is not working on a new aquilex system.The deficit jumps wildly, and when testing the system dayna reported the deficit was 800ml after dispensing 800ml of fluid.Replacing c&s.Rep was present.No patient impact reported.Awareness/procedure date (b)(6) 2021".

• Brand Name: AQUILEX FLUID CONTROL 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: 11618203
• Report Number: 3002914049-2021-00004
• Device Sequence Number: 14199945
• 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): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1