MAUDE Adverse Event Report: GRACE MEDICAL, INC. CARTILAGE MICROTOME; CUTTER, SURGICAL

Model Number 990-001

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Microtome 990-001 lot # unknown - the distributor reported faulty/damaged microtome.The blade stuck in the handle, and an or nurse cut their finger trying to get it out.There was no mention of difficulty inserting the blade into the handle.If there was an issue with the fit of the blade into the handle, it should have been obvious to the user, as there would have been difficulty in installing the blade, as the interference would exist both before and after installation.The blade was not returned for evaluation.Functional testing using new blades with the returned device showed that the blades were easily inserted and removed from the handle.Warnings are clearly stated in the instructions for use that the microtome contains sharp objects and should be handled with care.The device also has a laser marked warning sharp elements symbol.Additionally, there is a note in the ifu stating "to avoid difficulty in removal of blade from cartilage knife, do not use excessive force when pressing downward." it is unknown if the doctor used excessive force or not.Due to an interference fit between the blade and handle, it is indeterminate if this may have caused or contributed to the injury.

Event Description

On (b)(4) 2019, a distributor reported a faulty/damaged microtome ref 990-001, lot # unknown.The blade stuck in the handle, and an operating room nurse cut their finger trying to remove it.It was reported that this resulted in a severe cut to the right index finger on (b)(6) 2018, and that the nurse was not able to scrub for two to three weeks and is still experiencing sensitive feeling to date.There were no consequences for the patient.

• Brand Name: CARTILAGE MICROTOME
• Type of Device: CUTTER, SURGICAL
• Manufacturer (Section D): GRACE MEDICAL, INC.; 8500 wolf lake drive; suite 110; memphis TN 38133 4104
• Manufacturer (Section G): GRACE MEDICAL, INC.; 8500 wolf lake drive; suite 110; memphis TN 38133 4104
• Manufacturer Contact: bill graham ; 8500 wolf lake drive; suite 110; memphis, TN 38133-4104 ; 9013860990
• MDR Report Key: 8720496
• MDR Text Key: 148744429
• Report Number: 1000022662-2019-00002
• Device Sequence Number: 1
• Product Code: FZT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 990-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Date Manufacturer Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention