MAUDE Adverse Event Report: AESCULAP, INC. ROUND FILTER W/O INDICATOR; STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES

Model Number US994

Device Problems Contamination (1120); Material Discolored (1170)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was an issue with a round filter.Black specks were found on the sterile filter within the instrument container.This occurred during a neurological procedure.There was no patient harm or intervention required.The incident caused a 20-minute delay in surgery.

Manufacturer Narrative

Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.An investigation of the device manufacturing records was not able to be conducted by the manufacturer as lot # of the device in question was not known.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.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: ROUND FILTER W/O INDICATOR
• Type of Device: STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
• Manufacturer (Section D): AESCULAP, INC.; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 9330352
• MDR Text Key: 167323211
• Report Number: 2916714-2019-00125
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• PMA/PMN Number: K944864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US994
• Device Catalogue Number: US994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1