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

Model Number JK090

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event 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).

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
• Type of Device: DISPOSABLES CONTAINER SYSTEM
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11890449
• MDR Text Key: 265654345
• Report Number: 9610612-2021-00412
• Device Sequence Number: 1
• Product Code: FRG
• UDI-Device Identifier: 04038653341788
• UDI-Public: 4038653341788
• Combination Product (y/n): N
• PMA/PMN Number: K041623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: JK090
• Device Catalogue Number: JK090
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 05/28/2021
• Supplement Dates FDA Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1