MAUDE Adverse Event Report: GYRUS ACMI, INC MULTIDEBRIDER POWER CONSOLE

Model Number	MDCONS100
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device referenced in this report was not returned for evaluation, therefore the device evaluation could not be completed at this time.The exact cause of the reported event could not be conclusively determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The user facility reported that during a functional endoscopic sinus surgery (fess), the device did not work as intended.The burr had initially worked, then eventually stopped completely.A console and two (2) separate handpieces were used with the burr for testing, however the issue remained.The drill was taken from the handpiece and it was observed that part of the white piece of plastic in the drill where the drill is inserted into the handpiece was chipped up.The procedure was prolonged over an hour and was then aborted due to a lack of burrs.The patient had to be rescheduled for a new procedure.There was no patient harm reported.The device was inspected prior to the procedure and no damage or abnormalities were observed.The user facility later reported that the reason why the burrs broke was that they were used on a patient with an osteoma.The bone tissue was too hard for the burr to drill away.The rotation speed of the shaver became too small to handle this.The customer acknowledged that burrs were used in a procedure they are not intended to be used in.This complaint is related to patient identifiers; (b)(6).
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information that was received from the user facility and the legal manufacturer¿s investigation.Per the customer, there were no comorbidities as the patient was a healthy young man.The cause of the surgery was due to a large osteoma that grew into the orbit and resulted in reduced mobility and double vision.Everything went as planned during the surgery except that the equipment did not work and they did not get the last part of the osteoma.The legal manufacturer performed an investigation.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.As the device was not return for physical inspection, the definitive root cause of the console not working as intended could not be confirmed.However, per the functional checklist for the diego elite console, the console undergoes functional tests with the appropriate test equipment to ensure proper activation at specific settings, such as 40w.It is unlikely for the console to leave manufacturing without proper activation or function.This implies the damages were likely incurred as a result of transportation or customer use.The ifu (instruction for use) notes the following guidelines: the diego elite system, including image guided surgery compatibility, and optional suction console, is intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ent, sinus / rhinology, nasopharyngeal / laryngology, and head & neck procedures.It was not noted in the instructions for use that the device may be used on patients with osteoma.

• Brand Name: MULTIDEBRIDER POWER CONSOLE
• Common Device Name: MULTIDEBRIDER POWER CONSOLE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11344227
• Report Number: 1037007-2021-00018
• Device Sequence Number: 12020812
• Product Code: GEI
• UDI-Device Identifier: 00821925027770
• UDI-Public: 00821925027770
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K123429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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
• Operator of Device: Health Professional
• Device Model Number: MDCONS100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BUR3070DB, BURR, 3MM, 70DEG, DIAMOND BULLET, 5/PK; MDHP100S, MULTIDEBRIDER HANDPIECE, STRAIGHT; MDHP100S, MULTIDEBRIDER HANDPIECE, STRAIGHT