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

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2020

Event Type  malfunction  

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 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.

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
• Type of Device: DIEGO / DIEGO ELITE BLADES AND BURRS
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11159136
• MDR Text Key: 241861669
• Report Number: 1037007-2021-00007
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00821925041301
• UDI-Public: 00821925041301
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 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
• 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: 01/04/2021
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1