OLYMPUS SINGLE USE ASPIRATION NEEDLE

Report

• Report Number: MW5087097
• Event Type: Malfunction
• Date Received: June 3, 2019
• Date of Event: May 16, 2019
• Report Date: May 28, 2019
• Manufacturer: OLYMPUS SURGICAL TECHNOLOGIES AMERICA
• Product Code: FCG
• Product Problem: Yes
• Report Source: Voluntary report
• Reporter Location: FL, US
• Reporter Occupation: RISK MANAGER

Narratives

Description of Event or Problem · 1

NEW NEEDLES. NEEDLE WOULD NOT RETRACT BEING USED FOR BRONCHOSCOPY. TWO SEPARATE EVENTS (TWO NEEDLES) INVOLVING ISSUE WITH NEEDLE RETRACTION. NEEDLES WERE PUT THROUGH SCOPE AND IN ONE CASE THE NEEDLE WOULD NOT RETRACT AND DAMAGED THE SCOPE. NEEDLES ARE BEING RETURNED TO THE MFR'S REP. ON (B)(6) 2019, OLYMPUS NEEDLE WAS BEING USED IN ULTRASOUND BRONCHOSCOPE. THE NEEDLE WOULD NOT RETRACT. THE SCOPE WAS DAMAGED DURING THE EVENT. NO PT HARM NOTED. ON (B)(6) 2019, OLYMPUS NEEDLE WAS BEING USED FOR BRONCHOSCOPY. ISSUES WITH ABILITY FOR NEEDLE RETRACTION. BOTH NEEDLES WERE RETAINED AND WILL BE RETURNED TO THE MFR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
458382	OLYMPUS SINGLE USE ASPIRATION NEEDLE	22 GAUGE BRONCH ASPIRATION NEEDLE / BIOPSY NEEDLE	FCG	OLYMPUS SURGICAL TECHNOLOGIES AMERICA	NA-U401SX-4022	FR832679
458383	OLYMPUS SINGLE USE ASPIRATION NEEDLE	22 GAUGE BRONCH ASPIRATION NEEDLE / BIOPSY NEEDLE	FCG	OLYMPUS SURGICAL TECHNOLOGIES AMERICA	NA-U401SX-4022	FR832679

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• No Known Impact Or Consequence To Patient

Product problems · 2

• Break
• Retraction Problem

Type of report · 1

• Initial submission