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

Model Number	JK100
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
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 that there was an issue with jk100 - filter retention plate.According to the complainant, black particles were detected.Hospital says getting micro black flakes which they believe are from basket feet and/or retention plates.The complaint device was 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).
Event or Problem Description
Involved components: jn440 - bottom f/1/1 cont.Perforat.Height:90mm - lot unknown, jn441 - bottom f/1/1 cont.Perforat.Height:120mm - lot 52588251, jk441 - bottom for 1/1 container height:120mm - lot 52582372, jk489 - full-size lid w/retention plate silver - lot 52582372, jf223r - 1/1 size perf basket 540x253x76mm - lot 52685831, jf112210 - foot for perforated baskets - lot unknown, jk489 - full-size lid w/retention plate silver - lot 52591143, and jk489 - full-size lid w/retention plate silver - lot 52631606.
Additional Manufacturer Narrative
Investigation results: visual investigation: all products arrived in a decontaminated condition.The leading devices, jk100, show water spots and partly corrosion.The container trays, lids, and the basket neither show black particles, nor any residues on their surface.The surface of these products show signs of use, in the form of scratches on the anodized coating.The investigation was carried out visually.No black particles could be determined on the provided products.The articles show normal signs of use.The filter holders have water spots and partly corrosion.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device was not possible.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: without further knowledge about the circumstances we assume, that a too high force was applid on the jaw during surgery.A material failure or a manufacturing error can be excluded.Conclusion and measures / preventive measures: due to the current deviation and according to the explanation above, the root cause of the problem is most probably reprocessing-related.Based upon the investigations results a capa is not necessary.

• Brand Name: FILTER RETENTION PLATE
• Common Device Name: ACCESSORIES FOR STERILIZATION
• 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: 12775548
• Report Number: 9610612-2021-00730
• Device Sequence Number: 3572319
• Product Code: FLE
• UDI-Device Identifier: 04038653202706
• UDI-Public: 4038653202706
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2022

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: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 11/08/2021; 02/10/2022
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 12/08/2021; 03/04/2022
• 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: JF112210 - LOT UNKNOWN; JF223R - LOT 52685831; JK441 - LOT 52582372; JK489 - LOT 52582372; JK489 - LOT 52591143; JK489 - LOT 52631606; JN440 - LOT UNKNOWN; JN441 - LOT 52588251
• Patient Sex: Unknown