MAUDE Adverse Event Report: RIVERPOINT MEDICAL MEDLED SAPPHIRE; OPERATING HEADLAMP

Model Number MLS01

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

An investigation on the unit could not be performed as it has not been returned for evaluation.A review of the dhr was performed and there were no issues noted with the lot.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 manufactured on 3/15/2018, shipped on 3/20/2018 and was out of warranty at the time that the event was reported.

Event Description

According to the reporter, "there has been damage to the cord, right at the joint where the lamp head is attached to the head-strap itself.There is also a lack of part of the insulation itself.This piece came loose during the operation and landed right next to the operating area itself.".

• Brand Name: MEDLED SAPPHIRE
• Type of Device: OPERATING 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: 10515042
• MDR Text Key: 211692225
• Report Number: 3006981798-2020-00007
• Device Sequence Number: 1
• Product Code: HPP
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2020

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 Number: MLS01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1