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

Model Number	JK100
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that a filter retention plate (part # jk100) was used during a procedure performed on an unknown date.According to the complainant, the filter holders spring off.The sample was produced in 2006 and repaired by moritz in 2017 [mm 97/18].On the basis of the gasket, it was determined that yard goods were installed.The complaint device has been returned to the manufacturer for evaluation.There was no described patient harm.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).Involved components: jk486 - full-size lid w/retention plate blue - lot unknown.
Event or Problem Description
Correction: patient harm changed from "na to significant surgery delay".There was a significant surgery delay.Additional information was not provided nor available.Additional information has been requested but not yet received as of this report.Additional patient information is not available.
Additional Manufacturer Narrative
Correction / additional information: b5: patient harm changed from "na to significant surgery delay".H3: device evaluated by manufacturer.H6: codes.Investigation results: visual investigation: the filter holders show no visible damages.One filter holding pin of the retention plate is deformed.The investigation was carried out visually with the digital camera.We carried out a visual investigation of the products and noted, that one filter holder pin of the retention plate is deformed.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.The review of risk assessment revealed that the overall risk level (severity 1(5) x probability of occurrence 3(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.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: 13661210
• Report Number: 9610612-2022-00043
• Device Sequence Number: 20066283
• Product Code: FLE
• UDI-Device Identifier: 04038653202706
• UDI-Public: 4038653202706
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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: 02/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 03/30/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: JK486 - LOT UNKNOWN
• Patient Sex: Unknown