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

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 306410752
• Report Number: 3002914049-2022-00007
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04056702006914
• UDI-Public: 04056702006914
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1