MAUDE Adverse Event Report: GYRUS ACMI, INC SMART STAPES PISTON .5 X 4.50 MM

Model Number 70145923

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

The referenced packaging and device were not returned for evaluation.The exact cause of the reported event could not be determined at this time.However, if the device is returned at a later dated, this report will be supplemented accordingly.To mitigate the risk of cross contamination/patient infection, the instructions for use manual cautions users to, "inspect all packages for punctures or evidence of contamination prior to opening.The products will remain sterile in an undamaged, unopened package.".

Event Description

Olympus was informed that prior to the start of a stapedectomy procedure, the sterile packaging of the device was inspected and found breached.The procedure was completed with another device of the same lot.There was no adverse outcome to the patient and or procedure reported.The sterile packaging of the device did not exhibit any dents, scratches, etc.Additionally, the user facility reported that the device packaging was inspected upon receipt of the shipment.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results.The smart stapes piston box returned by the user facility was reviewed.The lot mh599273 is no longer in stock.The sterile barriers of the outer box were placed correctly on the outside of the package.The pouch containing the product on the inside of the box was wide open.The most likely cause of the large opening of the pouch could possibly indicate a miss in sealing the package.Adequate procedures and verification are in place to catch packaging issues.This is an isolated event due to human error of an unchecked re-work process.

Manufacturer Narrative

This supplemental report is being submitted to provide the dhr review results.A review of the dhr and sealing log indicated there were no issues documented during the manufacturing of the device.

• Brand Name: SMART STAPES PISTON .5 X 4.50 MM
• Type of Device: SMART STAPES PISTON
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8660950
• MDR Text Key: 146941759
• Report Number: 2951238-2019-00897
• Device Sequence Number: 1
• Product Code: ETB
• Combination Product (y/n): N
• PMA/PMN Number: K003214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 70145923
• Device Lot Number: MH654624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1