MAUDE Adverse Event Report: GYRUS ACMI, INC DIEGO TRIGGER ENABLED HANDPIECE; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	70339001
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to an olympus service center for evaluation and the reported issue was confirmed.The issue was due to a faulty hand piece.In addition, there was a big dent on the irrigation port.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The user facility reported to olympus that the blade did not move on the diego trigger enabled handpiece.No patient harm was reported.
Additional Manufacturer Narrative
This is a supplemental report to correct the initial mdr.Upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: DIEGO TRIGGER ENABLED HANDPIECE
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11759679
• Report Number: 1037007-2021-00034
• Device Sequence Number: 19937088
• Product Code: ERL
• UDI-Device Identifier: 00821925011410
• UDI-Public: 00821925011410
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K020594
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: 70339001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1