MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM AQL-100S; HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM AND TUBE SET

Model Number	AQL-100CBS
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We have been informed of the following event: "problem description problem description caller: hologic employee (tm) name: (b)(6).Part ship date: (b)(6) 2022.Date of procedure: (b)(6) 2023.Date product support or hologic employee notified of issue reported: 5/4/2023.Issue reported: negative deficit.Troubleshooting performed: performed a manual count.Dr.Who performed the procedure: unknown.Patient status: no injury reported or pae.Replacement requested: yes.Is product returning for investigation: yes.Detailed description: thomas reports that during a procedure today, the deficit suddenly dropped and went down to -300 and continued to drop.A manual count was required to complete the case.Thomas also reports that similar issues have happened in other cases, however he does not know specific numbers.Thomas was present for the case today.".
Additional Manufacturer Narrative
No patient harm was reported.The description of the event is very poor and the end user has not re-sponded to our requests.However, the device was sent in for evaluation and it was determined that the weighing cells were warped.Therefore, it is confirmed that the scale malfunctioned.Deficit testing per-formed by the technical service of the manufacturer resulted in a deficit being too high, but it has not been confirmed that the displayed deficit has negative values.

• Brand Name: AQUILEX FLUID CONTROL SYSTEM AQL-100S
• Common Device Name: HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM AND TUBE SET
• 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 poststra[?]e 11; ludwigsstadt, 96337 ; GM 96337
• Manufacturer Contact: ellen giese ; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 17090023
• Report Number: 3002914049-2023-00005
• Device Sequence Number: 6172847
• Product Code: HIG
• UDI-Device Identifier: 04056702006556
• UDI-Public: 04056702006556
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2023

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: 05/23/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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