MAUDE Adverse Event Report: ARTHREX, INC. SYNERGY INSUF(ENGL ,GERM,FRENCH,SPANISH); INSUFFLATOR, LAPAROSCOPIC

Model Number	SYNERGY INSUF(ENGL ,GERM,FRENCH,SPANISH)
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ar-3290-0001 is showing a contamination error on the screen.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause of the reportable failure can be attributed to misuse due to using the incorrect cleaning detergent/procedure.

• Brand Name: SYNERGY INSUF(ENGL ,GERM,FRENCH,SPANISH)
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• 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: jared engle ; 8009337001
• MDR Report Key: 19219613
• Report Number: 1220246-2024-02652
• Device Sequence Number: 8198552
• Product Code: HIF
• UDI-Device Identifier: 00888867100817
• UDI-Public: 00888867100817
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K030837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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
• Operator of Device: Health Professional
• Device Model Number: SYNERGY INSUF(ENGL ,GERM,FRENCH,SPANISH)
• Device Catalogue Number: AR-3290-0001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 05/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown