MAUDE Adverse Event Report: GYRUS ACMI, INC SHAVER BLADE, 4MM, 40DEG, ROTATABLE, SERRATED, CLOSED, 5/PK

Model Number SB4040RC

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

Device was received at olympus (b)(4).Functional testing was not performed as the device was returned with blood stained and noted to be a biohazard.Visual inspection was performed based on appearance of the device and found no abnormalities in the shape of the device.Root cause of the issue is unknown as functional testing was not performed.Probable cause of the issue of outer blade does not rotate may be due to a manufacturing defect of the rotation knob and the cylinder of the inner blade was damaged.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during an ess (endoscopic sinus surgery), the device inner blade stopped rotating and then resumed rotation while exhibiting an abnormal noise and was not operating smoothly.No further details provided regarding the event.No patient harm or injury reported due to the event.No user injury reported.

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.The root cause of the reported issue was not identified.The device was not returned to oem (original equipment manufacturer) for evaluation, therefore a conclusive root cause could not be determined.Olympus will continue to monitor complaints for this device.

• Brand Name: SHAVER BLADE, 4MM, 40DEG, ROTATABLE, SERRATED, CLOSED, 5/PK
• Type of Device: SHAVER BLADE, 4MM, 40DEG, ROTATABLE, SERRATED, CLOSED, 5/PK
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10677392
• MDR Text Key: 238136558
• Report Number: 1037007-2020-00059
• Device Sequence Number: 1
• Product Code: EQJ
• 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: 11/13/2020

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: SB4040RC
• Device Lot Number: CA845575
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1