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U.S. Department of Health and Human Services

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

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ARTHREX, INC. NANOSCOPE HANDPIECE LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number NANOSCOPE HANDPIECE
Device Problems Controller (765); Screen (953); Signal Artifact/Noise (1036); Handpiece (3067)
Patient Problem Reaction (2414)
Event Date 11/11/2019
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 diagnostic shoulder arthroscopy while using the (b)(4)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 (b)(4) was discarded, and the filament/artifact was not retrieved.

 
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Brand NameNANOSCOPE HANDPIECE
Type of DeviceLAPAROSCOPE, 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 Key9631789
MDR Text Key177177227
Report Number1220246-2020-01612
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK190645
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
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 Received01/27/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNANOSCOPE HANDPIECE
Device Catalogue NumberAR-3210-0040
Device LOT Number1908273
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/01/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/27/2020 Patient Sequence Number: 1
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