MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM AQL-100S; HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM AND TUBE SETS

Model Number AQL- 100CBS

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2021

Event Type  malfunction  

Manufacturer Narrative

The units were not sent in for examination.Therefore, a malfunction that could fulfil the reporting criteria cannot be completely ruled out at present.Further attempts will be made to obtain more information about the complaint situation and to retrieve the units from the complainant.A follow-up report will be submitted.

Event Description

We have been informed of the following event: (b)(6), is reporting an oob failure.The customer has experienced issues with this system since receiving it about 2 months ago.They've been seeing inaccurate readings from the pump.Today's case, emily was present and when they connected the tissue sock, the deficit was reading -100.Since they didn't have another system, they had to perform a manual count instead.They ended up with about 100 as the deficit.Procedure completed and no patient injury.The tm is requesting that they be shipped another system as it's still under warranty.Setting up adv replacement.

Event Description

We have been informed of the following event: (b)(6) tm, is reporting an oob failure.The customer has experienced issues with this system since receiving it about 2 months ago.They've been seeing inaccurate readings from the pump.Today's case, emily was present and when they connected the tissue sock, the deficit was reading -100.Since they didn't have another system, they had to perform a manual count instead.They ended up with about 100 as the deficit.Procedure completed and no patient injury.The tm is requesting that they be shipped another system as it's still under warranty.Setting up adv replacement.

Manufacturer Narrative

The device issue is described as an out of box failure.The device should not be used if a defect is suspected or detected.The surgery team decided to use the device for 2 months despite regular deficit issues.Reasons why the deficit displayed by the pump does not correspond to the expected deficit, include uterine perforation, non-return of irrigation fluid to the waste containers, so the system cannot calculate the deficit (e.G.Fluid remaining on the floor, doctor's clothing or under-buttocks-drape; use of additional suction system with its own collection containers), wrong manual determination of the deficit or an actual malfunction of the device.The most possible root cause could either be one of the aforementioned device-independent issues or likely an actual malfunction (e.G.Defective weighing cell), as the complainant states an out of box failure.Five attempts have been made to gather further information including to retrieve the device for evaluation (mar 4, 2021, mar 9, 2021, mar 16, 2021 , mar 23, 2021 and mar 30, 2021).No further attempts to retrieve the device are required.In the event that further information will become available and the device is received respectively, the complaint will be reopened and the investigation to be conducted.

• Brand Name: AQUILEX FLUID CONTROL SYSTEM AQL-100S
• Type of Device: HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM AND TUBE SETS
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 11618165
• MDR Text Key: 264768437
• Report Number: 3002914049-2021-00002
• 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: 07/01/2021

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
• Initial Date Manufacturer Received: 03/02/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 03/02/2021
• Supplement Dates FDA Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1