MAUDE Adverse Event Report: AESCULAP AG REUSABLE FILTER FOR CONTAINER; DISPOSABLES CONTAINER SYSTEM

Model Number	JK090
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer 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 aeculap (b)(4) that a reusable filter for container (part # jk090) was damaged.According to the complainant, the filter was torn.The complaint device has not been returned to the manufacturer for evaluation.No patient involvement.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.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.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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: REUSABLE FILTER FOR CONTAINER
• Common Device Name: DISPOSABLES CONTAINER SYSTEM
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12087565
• Report Number: 9610612-2021-00457
• Device Sequence Number: 4358884
• Product Code: FLE
• UDI-Device Identifier: 04038653341788
• UDI-Public: 4038653341788
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K041623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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: JK090
• Device Catalogue Number: JK090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1