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

Model Number AQL-100CBS

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 03/05/2021

Event Type  malfunction  

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 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".

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 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
• Type of Device: HYSTEROSCOPIC INSUFFLATOR
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 11618203
• MDR Text Key: 246021592
• Report Number: 3002914049-2021-00004
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04056702006556
• UDI-Public: 04056702006556
• Combination Product (y/n): N
• PMA/PMN Number: K172040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1