MAUDE Adverse Event Report: AESCULAP AG FILTER RETENTION PLATE; STERILIZATION CONTAINERS

Model Number	JK100
Medical Device Problem Code	Device Difficult to Maintain (3134)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
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 jk100 - filter retention plate.According to the complaint description, black particles were detected.The customer found black specs inside of two retractor trays.This was suspected to be caused by/from the retention plates.There was no described patient harm.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Additional information/correction: h3 - evaluation h6 - codes updated atter review of the investigation, this case has been re-assessed.The complaint is now considered to be non-reportable, no malfunction.Investigation results: we could not find any black particles on the product, despite disassembling the fixture.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.Due to the circumstance that no failure/defect could be determined, the risk analysis is not applicable.Conclusion and measures / preventive measures: as described in the above analysis, no defect was found on the recordings or other black particles on the instrument.The product complies with the specification in all respects.Based upon the investigations results a capa is not necessary.

• Brand Name: FILTER RETENTION PLATE
• 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: 12657473
• Report Number: 9610612-2021-00671
• Device Sequence Number: 17263151
• Product Code: FLE
• UDI-Device Identifier: 04038653202706
• UDI-Public: 4038653202706
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K792558
• 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): 10/24/2023

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: JK100
• Device Catalogue Number: JK100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown