MAUDE Adverse Event Report: ARTHREX, INC. NANOSCOPE HANDPIECE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number NANOSCOPE HANDPIECE

Device Problem Image Display Error/Artifact (1304)

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

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported during three different procedures while using a quantity three ar-3210-0040 nanoscope handpiece from lot: 1908273, all nanoscope tablet controller screens displayed a very small filament/artifact within the joint.It was reported that the filament/artifact resembled a hair or thread like substance.The surgical areas on all three patients were not shaved prior to the insertion of the scope sheath.There were no attempts made during any of the procedures to remove or find the filament/artifact, and all cases were completed with no reports of patient harm or injury.There was an arthrex sales representative present during two of the three cases.The three complaint ar-3210-0040 have been discarded, and the filament/artifacts were not retrieved.The arthrex sales representatives as well as product management have asked multiple times for the surgeon and facility to retain the nanoscope camera used, as well as to retrieve and retain the filament/artifact if possible when this issue occurs but this has not happened.The rep stated a fourth unused ar-3210-0040 from the same lot was tested by the same surgeon on a cadaver in a lab environment.The unit was tested by first shaving the surgical area prior to inserting the nanoscope, and then not shaving the surgical area prior to insertion.However, during both testing measures no filament/artifact appeared on the controller screen.The fourth unit has been returned to arthrex for evaluation.The surgeon has been in direct contact with the product manager discussing the reported issue.Additional information received on 01/07/2020: the rep reported the testing of the fourth ar-3210-0040 (lot: 1908273) was done at the agency's local lab with only fluid and white background to see if any filaments were present.No filaments were present during the testing.The three incidents of filaments being visible during surgery occurred during knee scope procedures.The specific dates of the three procedures are currently unknown.The rep stated they are following up with the facility to obtain the specific dates of the three procedures, and if there are available images of the filament.There have been no reports/feedback of any patient issues related to the reported observations.Additional information received on 01/09/2020: the rep provided the three dates and procedure types of when a filament was seen while using ar-3210-0040 (lot: 1908273).Case (b)(4) records the (b)(6) 2019 diagnostic knee arthroscopy procedure.It was reported the surgeon¿s reaction to having seen a filament was not expressed as problematic, and the filament was not retrieved.The two other procedures have been documented under case (b)(4).

• Brand Name: NANOSCOPE HANDPIECE
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 9607433
• MDR Text Key: 189992398
• Report Number: 1220246-2020-01591
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00888867287839
• UDI-Public: 00888867287839
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: NANOSCOPE HANDPIECE
• Device Catalogue Number: AR-3210-0040
• Device Lot Number: 1908273
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/02/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other