MAUDE Adverse Event Report: OLYMPUS - ROSWELL ALLIGATOR BX FORCEPS HYSTEROSCOPE ACCESSORIES

Model Number FB-211D 6ZK

Device Problems Difficult to Open or Close (2921); Material Protrusion/Extrusion (2979)

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

Event Date 04/14/2017

Event Type  Injury  

Event Description

Alligators bx.Forceps (item#88331) model #fb-211d 6zk exp 2021 forceps were applied to endobronchial tissue and tissue removed.Scrub opened forceps to release tissue and wire protruded from and of forceps.Forceps would no longer open or close.Scrub reported that earlier the forceps were slow to open and close.

• Brand Name: ALLIGATOR BX FORCEPS HYSTEROSCOPE ACCESSORIES
• Type of Device: ALLIGATOR BX FORCEPS HYSTEROSCOPE ACCESSORIES
• Manufacturer (Section D): OLYMPUS - ROSWELL
• MDR Report Key: 6541090
• MDR Text Key: 74417658
• Report Number: MW5069525
• Device Sequence Number: 1
• Product Code: NWW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Model Number: FB-211D 6ZK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR