MAUDE Adverse Event Report: AESCULAP INC. AESCULAP AICON¿ CONTAINER; STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES

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

Event Date 05/23/2023

Event Type  malfunction  

Event Description

We have discovered that the ifu for the aesculap aicon containers says the containers are validated for a limited number and type of cannulated instruments.Under section 9, labeled ¿indications for use¿, the ifu provides validated lumen configurations.The relevant configuration from the provided table reads ¿4 stainless steel lumens with > 1mm id < 500mm l¿.This section appears to indicate that there are no circumstances under which more than four stainless steel lumens can be sterilized in the same container.There is a parallel problem with the aesculap steril container system ifu.Section 14, ¿indications for use¿ provides a table labeled ¿max no.Of lumens/lumen configuration¿ which, in the relevant section, reads ¿1 lumen with = 3mm i.D.X = 400mm l and a second lumen = 3.8mm i.D.X = 370mm l¿.This would appear to restrict the number of lumens in this system to two, and to further restrict the diameter of acceptable lumens.Contact was made to aesculap representative, for clarification.The representative was confident that the validations reflected in these ifus represent merely the minimum that aesculap had to demonstrate for fda clearance.Documentation was requested that the systems are validated beyond these restrictions, but none have been produced.

• Brand Name: AESCULAP AICON¿ CONTAINER
• Type of Device: STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate pkwy; center valley PA 18034
• MDR Report Key: 17469523
• MDR Text Key: 320511697
• Report Number: 17469523
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1