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	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing 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 reusable filter for container (part # jk090) was used during a procedure performed on (b)(6) 2021.According to the complainant, the filters appears torn at the base, in the center.No patient complications were reported as a result of this event.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Based upon new information received, this event was re-evaluated and is considered no longer reportable- no malfunction or serious injury.

• 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: 11890449
• Report Number: 9610612-2021-00412
• Device Sequence Number: 1413331
• Product Code: FRG
• 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): 06/22/2021

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: 04/29/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1