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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM; HYSTEROSCOPY PUMP AND SCALE
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W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM; HYSTEROSCOPY PUMP AND SCALE Back to Search Results
Model Number AQL-100CBS
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Due to a revision in company procedures after a recent internal audit, this historical event was determined to be reportable.Recall information: recall reported to fda on 2019-08-29.Recall coordinator: (b)(6) pa-c; commander, u.S.Public health service res (b)(4).
 
Event or Problem Description
We have been informed of the following event: "bent- (b)(6) tm contacted technical support to report that aquilex cart serial number (b)(4) is bent and giving negative deficit readings.It is hologic owned.Contact is (b)(6) rma (b)(4) tracking (b)(4).".
 
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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 Key9074424
Report Number3002914049-2019-00012
Device Sequence Number2448578
Product Code HIG
UDI-Device Identifier04056702006556
UDI-Public04056702006556
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K172040
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial
Report Date (Section B) 09/16/2019
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 No Information
Device Model NumberAQL-100CBS
Device Catalogue NumberAQL-100CBS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/15/2019
Initial Report FDA Received Date09/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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