MAUDE Adverse Event Report: GYRUS ACMI, INC SHAVER BLADE, 4MM, 40DEG, ROTATABLE, SERRATED, CLOSED, 5/PK; DIEGO / DIEGO ELITE BLADES AND BURRS

Model Number	SB4040RC
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is scheduled to be returned, but has not arrived yet.Upon completion of the investigation, or if additional information should become available, a supplemental report will be submitted.
Event or Problem Description
As reported, during an unspecified procedure, the olympus shaver blade was difficult to remove from the handpiece.According to the initial reporter, when the device was removed, the handpiece connection of the device was cracked.A spare blade device was connected and the procedure was completed.No patient impact of consequences were noted as a result of this event.
Additional Manufacturer Narrative
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: SHAVER BLADE, 4MM, 40DEG, ROTATABLE, SERRATED, CLOSED, 5/PK
• Common Device Name: DIEGO / DIEGO ELITE BLADES AND BURRS
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11159136
• Report Number: 1037007-2021-00007
• Device Sequence Number: 4498688
• Product Code: EQJ
• UDI-Device Identifier: 00821925041301
• UDI-Public: 00821925041301
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT-EQJ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2021

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: SB4040RC
• Device Lot Number: CA845575
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1