MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM; HYSTEROSCOPY PUMP AND SCALE

Model Number AQL-100CS

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

The event description is poor.The end user did not respond to further enquiries and did not return the device for evaluation yet.Further attempts will be made to obtain more information about the complaint situation and to retrieve the device from the complainant.A follow-up report will be submitted.

Event Description

We have been informed of the following event: "problem description: please refer to case 693940 involving s/n (b)(4) provided, the gentleman mentioned on (b)(6) 2020 the issue may be deficit related yet this may not be confirmed, procedure date (b)(6) 2020.This is one isolated case.Ts recommended appropriate troubleshooting found in the ifu to confirm proper fluid flow and deficit variance is within spec.No return required at this time, no injury and no damage reported." "(b)(6) 2020 (b)(6) contact ts to discuss the outcome of testing the unit.After repeated tests by following the operators manual the system reveals a repeated out of spec deficit tolerance.The gentleman also provided c&s s/n (b)(4), the gentleman prefers to return only the pump at this time and once the pump arrives will test the unit with the current c&s to confirm the issue".

Manufacturer Narrative

The complainant did not return the device and did not provide any further information, therefore the manufacturer has closed the file on this event.

Event Description

We have been informed of the following event: "problem description: please refer to case 693940 involving s/n (b)(6) provided, the gentleman mentioned on (b)(6) 2020 the issue may be deficit related yet this may not be confirmed, procedure date (b)(6) 2020.This is one isolated case.Ts recommended appropriate troubleshooting found in the ifu to confirm proper fluid flow and deficit variance is within spec.No return required at this time, no injury and no damage reported." "(b)(6) 2020 thomas contact ts to discuss the outcome of testing the unit.After repeated tests by following the operators manual the system reveals a repeated out of spec deficit tolerance.The gentleman also provided c&s s/n (b)(6), the gentleman prefers to return only the pump at this time and once the pump arrives will test the unit with the current c&s to confirm the issue.".

• Brand Name: AQUILEX FLUID CONTROL SYSTEM
• Type of Device: HYSTEROSCOPY PUMP AND SCALE
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 10395230
• MDR Text Key: 203863424
• Report Number: 3002914049-2020-00006
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04056702002145
• UDI-Public: 04056702002145
• Combination Product (y/n): N
• PMA/PMN Number: K112642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

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-100CS
• Device Catalogue Number: AQL-100CS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1