MAUDE Adverse Event Report: AESCULAP INC. ROUND FILTERS W/INDICATOR; STERILE TECHNOLOGY

Model Number US751

Device Problem Material Puncture/Hole (1504)

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

Event Date 09/23/2022

Event Type  malfunction  

Event Description

It was reported to aesculap inc.That a round filters w/indicator (part # us751) was used in a sterilization container present in the operating room (or) on (b)(6) 2022.According to the complainant, small pinholes were discovered in the filter.The complaint device has not yet been returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aic reference (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer evaluation: the device was returned to the manufacturer for physical evaluation.Functional testing was performed by exposing the filters to steam cycles; no filter issues observed post-sterilization.The device history records (dhr) were not able to be reviewed as no lot number was made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.The investigation into the cause of the reported problem was not able to confirm the failure mode of filter pinholes.Although no issues were observed, potential causes for the damage noted could be attributed to, but not limited to, steam quality and degree of moisture present in the sterilization process, effectiveness of steam removal at the end of the cycle, standing water on the filter, or aggressiveness of the sterilizer phase changes.Standing water for an extended period of time or excessive moisture on the filter material has the potential to impact the strength of the filter material.Aggressive phase changes during the sterilization cycle can place stress on the damp filter material.By aggressively pulling the fabric repeatedly into the mesh filter on the retention plate, integrity of the filter could be compromised.

• Brand Name: ROUND FILTERS W/INDICATOR
• Type of Device: STERILE TECHNOLOGY
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer (Section G): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: jonathan severino ; 3773 corporate parkway; center valley, PA 18034 ; 4847197287
• MDR Report Key: 15631985
• MDR Text Key: 303394148
• Report Number: 2916714-2022-00106
• Device Sequence Number: 1
• Product Code: KCT
• UDI-Device Identifier: 04038653473724
• UDI-Public: 4038653473724
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US751
• Device Catalogue Number: US751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1