MAUDE Adverse Event Report: AESCULAP AG REUSABLE FILTER FOR CONTAINER STERILE TECHNOLOGY

Model Number JK090

Device Problem Crack (1135)

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

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with jk090 - reusable filter for container. According to the complaint description, the filter were damaged/torn. Mainly, holes or cracks in the central circle are observed. It is difficult to say for sure how many passes these filters have undergone. The average estimate would be 190 passes with a minimum of 12 cycles and a maximum of 600. There was no described patient harm. Additional information was not provided nor available. The malfunction is filed under aag reference (b)(4). Associated medwatch-reports: 9610612-2020-00892 - 400494548 - jk090, 9610612-2020-00893 - 400494549 - jk090, 9610612-2020-00894 - 400494550 - jk090, 9610612-2020-00895 - 400494551 - jk090, 9610612-2020-00896 - 400494552 - jk090, 9610612-2020-00897 - 400494553 - jk090, 9610612-2020-00898 - 400494554 - jk090, 9610612-2020-00899 - 400494555 - jk090, 9610612-2020-00900 - 400494556 - jk090, 9610612-2020-00901 - 400494557 - jk090, 9610612-2020-00902 - 400494558 - jk090, 9610612-2020-00903 - 400494559 - jk090, 9610612-2020-00904 - 400494560 - jk090, 9610612-2020-00905 - 400494546 - jk090.

• Brand Name: REUSABLE FILTER FOR CONTAINER
• Type of Device: STERILE TECHNOLOGY
• 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: 11014975
• MDR Text Key: 221767583
• Report Number: 9610612-2020-00892
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K792558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: JK090
• Device Catalogue Number: JK090
• Device Lot Number: 4508732173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse