MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS MICROAIRE SMARTRELEASE HANDPIECE; CARPAL TUNNEL RELEASE HANDPIECE

Model Number 81014

Device Problem Retraction Problem (1536)

Patient Problems Exposure to Body Fluids (1745); Laceration(s) (1946)

Event Date 04/23/2019

Event Type  malfunction  

Manufacturer Narrative

Product evaluation has confirmed the reported issue of the blade not retracting following release of the handpiece's trigger.In response to this, microaire surgical instruments has initiated a capa to further investigate the cause of the confirmed issue with part# 81014, smartrelease handpiece and determine any necessary actions.

Event Description

It was reported that on (b)(6) 2019, following a carpal tunnel surgery using smart release handpiece (part# 81014 / either serial# (b)(4)) with standard blade assembly (part# 81010-6 / lot# 0119335385), the blade did not retract upon releasing the handpiece's trigger.Following the procedure, the unit was taken to the surgery center's decontamination room for disassembly and cleaning/sterilization.While removing the standard blade assembly from the smart release handpiece, the sterile processing technician did not realize that the blade on the standard blade assembly had not retracted and was cut on the hand.The cut was described as a puncture wound which did not require any medical intervention, aside from the technician being sent for infectious disease testing.The technician recovered fully with no known complications.

Manufacturer Narrative

During a review of complaint files, it was identified that a supplemental submission was not submitted for mdr# 2020601-2019-00004 to tie it to recall# 2020601-06-04-19-001-r which was initiated and submitted in june 2019.The recall has since been completed.This supplemental submission is being submitted to link the mdr with its corresponding recall.

• Brand Name: MICROAIRE SMARTRELEASE HANDPIECE
• Type of Device: CARPAL TUNNEL RELEASE HANDPIECE
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS; 3590 grand forks blvd.; charlottesville VA 22911
• MDR Report Key: 8642068
• MDR Text Key: 148413909
• Report Number: 2020601-2019-00004
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 81014
• Device Catalogue Number: 81014
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Date Manufacturer Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other