MAUDE Adverse Event Report: AESCULAP AG BOTTOM FOR 1/1 CONTAINER HEIGHT:90MM; STERILIZATION CONTAINERS

Model Number	JK440
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with jk440 - bottom for 1/1 container height:90mm.According to the complaint description, the silver metallic and black particles were noticed at the bottom of the instrument trays after the steam sterilization cycle.And in the chamber of the units.There was signifiant surgery delay, but it was found in sterile processing before the start of the operation.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).Involved components: jk489 - full-size lid w/retention plate silver - lot unknown.Jf949 - silicone cushioning pad 1/1 size - lot unknown.Jm020 - extra long mini cont.Lid non anodized - lot unknown.Jm021 - extra long mini cont.Bottom non anodized - lot unknown.
Additional Manufacturer Narrative
Investigation results: visual investigation: the investigation was carried out visually and microscopically with the digital microscope and the digital-camera.We made a visual inspection of the products.Here we detected black flakes, unknown residues, coatings and silicates, metallic particles and scratches on the surface.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 4 (5) probability of occurrence2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures/preventive measures: according to the quality standard a material defect and a production error can be excluded.Investigation leads to the assumption that the cause for the mentioned deviation most probably was caused by an improper handling.There is the possibility that the black flakes was caused by filter wear due to an improper loading of the container.If the container is heavy loaded there is the possibility that the filter holders start chafe.For this reason, among others, a medical grade plastic was selected for the closure mechanisms.Furthermore, the load that has been sterilized in the container may have cause the deviation described.Based upon the investigations results a capa is not necessary.

• Brand Name: BOTTOM FOR 1/1 CONTAINER HEIGHT:90MM
• Common Device Name: STERILIZATION CONTAINERS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12542955
• Report Number: 9610612-2021-00642
• Device Sequence Number: 14450807
• Product Code: FRG
• UDI-Device Identifier: 04038653130351
• UDI-Public: 4038653130351
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K053389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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: JK440
• Device Catalogue Number: JK440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JF949 - LOT UNKNOWN; JK489 - LOT UNKNOWN; JM020 - LOT UNKNOWN; JM021 - LOT UNKNOWN; JF949 - LOT UNKNOWN; JK489 - LOT UNKNOWN; JM020 - LOT UNKNOWN; JM021 - LOT UNKNOWN
• Patient Sex: Unknown