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

Model Number	AQL-100CS
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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".
Additional 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 or Problem 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
• Common Device Name: HYSTEROSCOPY PUMP AND SCALE
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 10395230
• Report Number: 3002914049-2020-00006
• Device Sequence Number: 11507085
• Product Code: HIG
• UDI-Device Identifier: 04056702002145
• UDI-Public: 04056702002145
• Combination Product (Y/N): N
• PMA/510(K) Number: K112642
• 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): 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
• Operator of Device: Health Professional
• Device Model Number: AQL-100CS
• Device Catalogue Number: AQL-100CS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1