MAUDE Adverse Event Report: GYRUS ACMI, INC. DISPOSABLE MYR BLADE WITH HANDLE

Model Number 70130791

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2015

Event Type  No Answer Provided  

Manufacturer Narrative

At the time of this report, the device has not yet been returned for evaluation.As a result, a determination cannot be made at this time.If further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly.

Event Description

It was reported that some packages were found unsealed at one end.

Manufacturer Narrative

The customer's complaint of an unseal pouch was confirmed.The returned product was reviewed and found that 100% of the lot was unsealed with no visible indications that the product had been run through the sealer.(b)(4) has been initiated to further investigate into the root cause of the issue.A review of the distribution data for the affected item and lot found that no affected product shipped to customers in the us.

Event Description

It was reported that some packages were found unsealed at one end.

• Brand Name: DISPOSABLE MYR BLADE WITH HANDLE
• Type of Device: BLADE
• Manufacturer (Section D): GYRUS ACMI, INC.; 2925 appling rd; bartlett TN 38133
• Manufacturer (Section G): GYRUS ACMI, INC.; 2925 appling rd; bartlett TN 38133
• Manufacturer Contact: angela caputo ; 136 turnpike rd; southborough, MA 01772 ; 5088042667
• MDR Report Key: 5150812
• MDR Text Key: 28650344
• Report Number: 1037007-2015-00009
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 70130791
• Device Lot Number: SD954316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2014
• 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