MAUDE Adverse Event Report: MEDLINE RENEWAL MICROAIRE; CARPAL TUNNEL RELEASE BLADE ASSEMBLY, (WHITE)

Catalog Number 81010R

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/25/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that through examination under a microscope, microscopic black specks were visualized in the post-carpal tunnel surgery wound.It was suspected that the microscopic black specks were from the reprocessed microaire's carpal tunnel release blade assembly.Per report, these microscopic black specks were successfully removed from the patient through an unidentified method.There was no report of prolonged anesthesia, a serious injury or another adverse patient event related to the reported incident.Due to the reported incident and in an abundance of caution, this medwatch is being filed.The sample was not available to be returned for evaluation.Companion samples from the reported lot number were returned and the reported complaint is confirmed.A root cause could not be determined at this time.No additional information is available.If additional relevant information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that microscopic black specks from the reprocessed microaire's carpal tunnel release blade assembly were noted in the wound post carpal tunnel surgery.

• Brand Name: MICROAIRE
• Type of Device: CARPAL TUNNEL RELEASE BLADE ASSEMBLY, (WHITE)
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• Manufacturer Contact: stephen wilson ; 1500 ne hemlock ave; redmond, OR 97756
• MDR Report Key: 8079169
• MDR Text Key: 128324232
• Report Number: 3032391-2018-00018
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10888277375529
• UDI-Public: 10888277375529
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 81010R
• Device Lot Number: 375194
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention