• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. APOLLORF¿ XL90, ASPIRATING ABLATOR 90°; ELECTROSURG CUT/COAG DEVICE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARTHREX, INC. APOLLORF¿ XL90, ASPIRATING ABLATOR 90°; ELECTROSURG CUT/COAG DEVICE Back to Search Results
Model Number APOLLORF¿ XL90, ASPIRATING ABLATOR 90°
Device Problem Flaked (1246)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2023
Event Type  malfunction  
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.If the device becomes available for evaluation, a follow-up report will be submitted.
 
Event Description
On 08/03/2023, it was reported by an arthrex employee via sems that an ar-9821 apollorf xl90s black colored coating was flaking off the sides of the probe.This occurred during a hip arthroscopy procedure on (b)(6) 2023, there was no injury to the patient however the doctor spent an extra two minutes retrieving the pieces out of the hip joint and finished the case with a ar-9821.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
APOLLORF¿ XL90, ASPIRATING ABLATOR 90°
Type of Device
ELECTROSURG CUT/COAG DEVICE
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
emily shafer
8009337001
MDR Report Key17661128
MDR Text Key322386093
Report Number1220246-2023-07691
Device Sequence Number1
Product Code GEI
UDI-Device Identifier00888867267220
UDI-Public00888867267220
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161581
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 08/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAPOLLORF¿ XL90, ASPIRATING ABLATOR 90°
Device Catalogue NumberAR-9821
Device Lot Number15105395
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/03/2023
Initial Date FDA Received08/31/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-