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

Model Number NANOSCOPE HANDPIECE

Device Problems Signal Artifact/Noise (1036); Contamination /Decontamination Problem (2895)

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

Event Date 11/08/2019

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 a bilateral diagnostic knee arthroscopy while using the ar-3210-0040 nanoscope handpiece (lot: 1908273), the 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 area on the patient was not shaved prior to the insertion of the scope sheath.There were no attempts made during the procedure to remove or find the filament/artifact, and the case was completed with no reports of patient harm or injury.It was reported that the surgeon¿s reaction to having seen a filament was not expressed as problematic.The complaint ar-3210-0040 was discarded, and the filament/artifact was not retrieved.

• 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: 9631767
• MDR Text Key: 189909505
• Report Number: 1220246-2020-01611
• 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: Other
• Type of Report: Initial
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• 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?: No
• Date Manufacturer Received: 01/09/2020
• 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