MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED TRIPLE; SURGICAL LIGHT

Model Number 1565161

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

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

Event Date 07/25/2018

Event Type  malfunction  

Manufacturer Narrative

It is known that improper installation, maintenance or a collision can lead to the spring arm joint cover falling.The device is still being investigated by an olympus (b)(4) technician.A follow-up report will be submitted if new pertinent information is obtained.

Event Description

During a neurological procedure, the plastic strip of a iled triple's ac3000 arm joint cover fell on the patient.There were no reports of any injury to the patient or impact to the procedure.

• Brand Name: ILED TRIPLE
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318
• Manufacturer Contact: steffen ulbrich ; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318
• MDR Report Key: 7850320
• MDR Text Key: 119670309
• Report Number: 9681407-2018-00046
• Device Sequence Number: 1
• Product Code: FQP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K061317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1565161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1