MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED5; SURGICAL LIGHT

Model Number 1663720

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) discussed with trumpf medical and external maintenance provider (b)(4).Handle disinfected and quarantined - no apparent damage to the locking hole.(b)(4) engineer inspected the iled light head on evening of (b)(6) 2017.(b)(4) are working to establish whether mechanism failure or user error in locking /inadvertent unlocking of handle.The light head (including handle locking) was tested by (b)(4) during a scheduled annual maintenance visit on 8th august 2016.The investigation is currently ongoing and a follow up report will be submitted if relevant information is discovered.

Event Description

During a surgical procedure, the operating light was being positioned when the protective sterile light handle became detached and fell into sterile field impacting the thoracic retractor causing the glass/plastic part of the handle to break.The broken glass pieces of the handle fell into the wound and the surrounding sterile field.The surgeon removed all the glass particles that he could see in the thoracic cavity and the wound was washed with 2 litres of saline.An x-ray was performed and 3 tiny specks were seen on the x-ray.Another wash with 2 litres was performed before closure.In the surgeons opinion the size of these fragments would cause no harm to the patient.

Manufacturer Narrative

The handle was manufactured in 2011.Per the user manual, handles that are routinely sterilized have a limited lifetime of 1.5 years.A review of a photo of the defective handle shows significant visible marks which lead to the conclusion that multiple sterilization cycles were performed and per the date of manufacture the handle was continuing to be used past the lifetime of a routinely sterilized handle manufactured in 2011.

• Brand Name: ILED5
• 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: 6743920
• MDR Text Key: 81302695
• Report Number: 9681407-2017-00026
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• 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: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1663720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2011
• 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