MAUDE Adverse Event Report: GYRUS ACMI, INC SPEAR ANGLED MYRINGOTOMY BLADE,DISP (12PK)

Model Number 70130794

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

The service center followed up with the user facility regarding the reported event.Per the customer, the device should have been a myringotomy blade with a round shaft, however the package contained a myringotomy blade with a tapered shaft.The customer returned two boxes (23 pieces total) of 70130794 spear angled myringotomy blade (lot me838233) for evaluation.The user's complaint was been confirmed.A visual inspection was performed on one of the twenty-three returned devices, and identified that the device inside the sealed package differs from that printed on the label.The received device packaging was intact, and properly sealed.One device, for testing was removed from the package and compared to a picture of the related model referenced in the guide.Based on the shape of the tip of the received device, the product deviation was confirmed.The received device has a tapered-straight edge angled down cut indicating that the model is a 70130928.The 70130794 that should be in the package, has a spear micro-point angled blade at the tip.The subject devices will be forwarded to the manufacturer¿s site for further investigation.

Event Description

The service center was informed that during preparation for use the customer noted that the blade received did not match the packaging label.The user facility reported previously using this product and noticed that the tip was different and the shaft was thicker.The device was not used on a patient.The scheduled procedure was completed with different blade.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received from the original equipment manufacturer (oem).Please see the updates in sections: g4, g7, h2 and h10.The device was inspected upon receipt at the olympus bartlett facility, market quality engineer.The device was packaged as model 70130794 but contains model 70130928.The distal end of packaged device is a downward angled straight edge with a larger shaft diameter at proximal end.The distal end of model 70130794 is spear tip with a smaller shaft diameter.The evaluation did confirm the customer's report.The manufacturing site is conducting an investigation to determine the cause of the mixed / incorrect product packed and shipped from bartlett facility.A review of the dhr was performed and found no deviations or anomalies with the manufacturing of this product.

• Brand Name: SPEAR ANGLED MYRINGOTOMY BLADE,DISP (12PK)
• Type of Device: SPEAR ANGLED MYRINGOTOMY BLADE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 9458268
• MDR Text Key: 204567276
• Report Number: 2951238-2019-01215
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70130794
• Device Lot Number: ME838233*
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 01/20/2020
• Supplement Dates FDA Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1