MAUDE Adverse Event Report: GYRUS ACMI, INC SHAVER BLADE, 4MM, STRAIGHT, STANDARD, TYPE A, DS, 5/PK

Model Number SB4000SA

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the device approximately 10 to 15 minutes during the endoscopic sinus surgery (ess) procedure, the blade axis broke in the nasal cavity.According to the reporter, the subject device was replaced with the same similar device and the intended procedure was completed with no harm or impact to the patient.

Manufacturer Narrative

This supplemental report is being submitted to provide the review of the device history records (dhr).The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Physical inspection of device could be performed as the device was discarded at the medical facility.As the device was not returned to the oem (original equipment manufacturer) for physical inspection, a root cause cannot be determined for the reported failure.Olympus will continue to monitor complaints for this device.

• Brand Name: SHAVER BLADE, 4MM, STRAIGHT, STANDARD, TYPE A, DS, 5/PK
• Type of Device: SHAVER BLADE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10311070
• MDR Text Key: 201873338
• Report Number: 1037007-2020-00024
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT-EQJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SB4000SA
• Device Lot Number: NC801099
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1