MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED; ILED TRIO/QUAD

Model Number ILED 3/5

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Device Issue (2379)

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

Event Date 02/28/2017

Event Type  malfunction  

Manufacturer Narrative

The affected adapter was not available when the service technician arrived.It could not be located.Service tested adapters from other operating rooms and all worked as intended.No failures detected.Attempts to get the affected adapter back for investigation are ongoing.Attempts to recover part ongoing.

Event Description

During a surgery the sterile handle adapter of the iled trio/quad surgical light fell down and landed on the patient.No injury reported.

Manufacturer Narrative

The returned adapter was investigated by trumpf medical.All dimensions are in the acceptable tolerance range, there are no abnormalities or damage noted on the adapter.The potential causes of the event are the adapter was not correctly secured at the light head or a blockage of the notch on the lamp head was existing, which led to inability to lock correctly.The light head itself was inspected by the service technician in march 2017, no malfunction or defect was noted.Trumpf medical was unable to reproduce the failure.

• Brand Name: ILED
• Type of Device: ILED TRIO/QUAD
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318
• Manufacturer (Section G): 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 ; 6715864140
• MDR Report Key: 6442055
• MDR Text Key: 71415372
• Report Number: 9681407-2017-00011
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K061317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ILED 3/5
• Device Catalogue Number: 4028310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2014
• 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