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 Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
We have been informed of the following event: "(b)(4): brief description.Deficit dropped to -999 during procedure.Problem description reporter: (b)(6), part returning description: date of procedure: (b)(6) 2022, date product support or hologic employee notified of issue reported: (b)(6) 2022, issue reported: deficit dropped to -999 during procedure.Troubleshooting performed: during a hysteroscopy, the deficit suddenly dropped to -999.The procedure was aborted shortly after as the surgeon perforated with the scope (case 01120410).This deficit issue has happened in a previous case (case 01095004) where the deficit suddenly dropped from 2000 to 200.None of the bags or canisters were being touched when this happened.The system was facing away from v.At the time of deficit change, v.Was notified by a scrub tech that it happened.Power cable was not draped over system or canisters during procedure.The deficit changed after the perforation occurred, however v.States the procedure was very quick.V.Did deficit/flow rate tests and scale test, and the system passed.How did the procedure complete: aborted.Patient status: no injury reported or p.Ae.Dr.Who performed the procedure: replacement requested: n.Is product returning for investigation: n.Site contact information: additional procedure information: recommended exchange to vendela, she will follow up with customer.Patient/user impact.No impact reported.(b)(4): brief description, pae - perforation.Problem description reporter: (b)(6).Serial number or lot number of reported item: unknown.Date of procedure: (b)(6) 2022.Date product support or hologic employee notified of issue reported: 8/23/22.Issue reported: perforation during hysteroscopy.Troubleshooting performed: v.Reports that during a procedure, doctor perforated uterus while using an omni scope and aquilex system.Procedure was aborted at that time.No further information is known.How did the procedure complete: procedure was aborted.Patient status: patient condition unknown.Dr.Who performed the procedure: unknown.Replacement requested: n.Is product returning for investigation: n.Site contact information: additional procedure information: reporting issue, nothing returning.Closing case.Patient/user impact.No information available.".

• 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 GMBH; alte poststrasse 11; ludwigsstadt, 96337 ; GM 96337
• Manufacturer Contact: ellen giese ; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 15476431
• Report Number: 3002914049-2022-00008
• Device Sequence Number: 20351365
• Product Code: HIG
• UDI-Device Identifier: 04056702006914
• UDI-Public: 04056702006914
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2022

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: 08/26/2022
• Initial Report FDA Received Date: 09/24/2022
• 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