MAUDE Adverse Event Report: GYRUS ACMI, INC BURR, 3MM, 70DEG, DIAMOND BULLET, 5/PK

Model Number BUR3070DB

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2020

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 during a functional endoscopic sinus surgery (fess) procedure, the device did not performed as intended.According to the reporter, 3 pieces of burrs were opened and none of them worked.The user changed the handpieces and consoles however, the issue was not resolved.A straight burr was opened and the intended procedure was completed.The or (operating room) time was increased to approximately 2 hours and 17 minutes due to the event.There were no further details provided due to the event.No patient harm or injury reported.No user injury reported.This is related to patient identifiers (b)(6).

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The device was returned and there was no sign of damage with model: bur3070db and lot:ca845666.The customer¿s phenomenon of the burr not working as intended was not confirmed.The original equipment manufacturer (oem) performed a device history record review and no abnormalities were noted.This product with lot ca845666 was manufactured on within specification.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The root cause could not be determined as the customer phenomenon could not be identified.Due to device having passed all functional tests and having no visual abnormalities and evidence of device being inspected by manufacturing prior to being shipped to the customer by dhr evaluation, it is unlikely the unit left the facility damaged.Therefore, the damages incurred may have been as result of transportation or use.Olympus will continue to monitor the field performance of this device.

• Brand Name: BURR, 3MM, 70DEG, DIAMOND BULLET, 5/PK
• Type of Device: BURR, 3MM, 70DEG, DIAMOND BULLET, 5/PK
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10734003
• MDR Text Key: 213054009
• Report Number: 1037007-2020-00072
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BUR3070DB
• Device Lot Number: LOTCA845666
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1