MAUDE Adverse Event Report: RIVERPOINT MEDICAL MEDLED; SURGICAL HEADLAMP

Model Number MLS01

Device Problem Break (1069)

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

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

An investigation on the unit could not be performed as it has not been returned.The ifu for the medled headlamp states "this headlamp purchased new is warranted to be free from original defects in material and workmanship under normal use and service for a period of one year from the date of first shipment from manufacturer." the unit was purchased and shipped on 3/25/2016 and was out of warranty at the time of the event.Trending analysis shows that this is the first complaint for this headlamp unit since release and the first complaint of a component breaking off and falling into the surgical field.

Event Description

According to the reporter, "bezel cable was somehow torn when in use in a vascular srugery procedure and the torn piece fell into the operative field.Fortuantely, it did not fall into the patient, but instead on the surgical sheet.The piece was removed from the sheet in the surgical field and discarded.".

• Brand Name: MEDLED
• Type of Device: SURGICAL HEADLAMP
• Manufacturer (Section D): RIVERPOINT MEDICAL; 825 ne 25th ave.; portland OR 97232
• Manufacturer (Section G): RIVERPOINT MEDICAL; 825 ne 25th ave.; portland OR 97232
• Manufacturer Contact: amanda cole ; 825 ne 25th ave.; portland, OR 97232 ; 5035178001
• MDR Report Key: 9598446
• MDR Text Key: 204196240
• Report Number: 3006981798-2020-00002
• Device Sequence Number: 1
• Product Code: HPP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MLS01
• Device Lot Number: 140825-00008908
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1