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

Model Number	AQL-100CBS
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
We were notified of the following event: "information received by email on june 6, 2019 from area rep c/o customer (b)(6) (email ccd) (b)(6) stating "the following account has a scale calibration issue that needs to be repaired immediately.We were in a hysteroscopy case yesterday (b)(6) 2019.During the case, the deficit fluctuated from a positive number all the way up to 210 down to a negative 180.Intermittently during the case.A test was run on the unit and it ran negative in the end as well.Please have a replacement unit sent to this facility asap as they are down to one usable unit.(b)(6).(b)(4)."".
Additional Manufacturer Narrative
The device has been returned to the manufacturer w.O.M.World of medicine gmbh on 5th of august 2019.The device was in a condition where it should not have been used for surgery.Relevant findings: - the bag deflector is missing - the left hook is broken - right hook is bent - both trays are bent - the scale pole is bent see also pictures attached.The instructions for use states in - chapter 6 functional check: "perform a visual check of the devices.Do not use the system in case of obvious damage." - chapters 3 purpose and 5 system operation : "warning! do not use this system if a defect is suspected or detected during the function check.This also applies to obvious defects, especially defects and damage to the power plug and power cord." - chapters 3 purpose and 6 functional check: "warning! the functional test must be performed prior to each device use." the root cause of the complaint is therefore the improper handling of the device and the use of the device despite numerous obvious damages.

• 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: 8767233
• Report Number: 3002914049-2019-00007
• Device Sequence Number: 16566616
• Product Code: HIG
• UDI-Device Identifier: 04056702006556
• UDI-Public: 04056702006556
• Combination Product (Y/N): N
• PMA/510(K) Number: K172040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2019

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: 08/05/2019
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 09/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1