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

Model Number	AQL-100PBS
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
We have been informed of the following event: follow up called in yesterday - aql deficit issues.Reporter: (b)(6) for account (if not reporter): part returning description: rm-aql-100pbs serial number of reported item: (b)(4).Date product support or hologic employee notified of issue reported: (b)(6) 2022.Issue reported: deficit-80ml.Troubleshooting performed: (b)(6) explained that the customer ran into a final deficit of -80ml in a recent procedure (finding out date).(b)(6) advised to run a fluid deficit test.(b)(6)explained that this also had a -80ml final reading.(b)(6) will also run a scale test to confirm a damaged scale.Sent (b)(6) the deficit questions.Waiting on reply.How did the procedure complete: yes.Patient status: no.Injury reported or pae.Dr.Who performed the procedure: unknown.Replacement requested: y.Is product returning for investigation: unsure.Patient/user impact no impact reported.08.09.2022 additional information from hologic: the case was closed for our customer service department since unfortunately, we couldn't get any answer back from customer after 3 attempts.

• Brand Name: AQUILEX FLUID CONTROL SYSTEM AQL
• Common Device Name: HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM AND TUBE SETS
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE; alte poststrasse 11; ludwigsstadt 96337 ; GM 96337
• Manufacturer Contact: ellen giese ; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 15427884
• Report Number: 3002914049-2022-00007
• Device Sequence Number: 4680000
• Product Code: HIG
• UDI-Device Identifier: 04056702006914
• UDI-Public: 04056702006914
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K172040
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2022

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-100PBS
• Device Catalogue Number: AQL-100PBS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown