MAUDE Adverse Event Report: GYRUS ACMI, INC SHAVER BLADE, 2MM, STRAIGHT, STANDARD, TYPE A, 5/PK

Model Number SB2000SA

Device Problem Activation Problem (4042)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

The actual blade was connected to the console handpiece owned by the hinode plant, and the reproduction was confirmed.Since the console did not recognize the blade connection, the phenomenon that did not work was reproduced.No abnormality was found in the appearance.The outer blade and inner blade could be operated manually.Based on the evaluation results, it was presumed to be electrical contact part or substrate wiring inside the blade likely attributed to the user¿s experience.The dhr review of the sb2000sa, serial number (b)(4) did not find any defects, nonconforming issue or any corrective action issues during the assembly build of the unit.

Event Description

The service center was informed that during an unspecified procedure, the blade stopped working.The blade was replaced and the procedure was completed.There was no patient health hazard.

• Brand Name: SHAVER BLADE, 2MM, STRAIGHT, STANDARD, TYPE A, 5/PK
• Type of Device: SHAVER BLADE, 2MM, STRAIGHT
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 2925 appling rd; bartlett, TN 38133 ; 9013785969
• MDR Report Key: 10114436
• MDR Text Key: 209635087
• Report Number: 1037007-2020-00005
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/03/2020

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: SB2000SA
• Device Lot Number: NC801696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 06/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1