MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED 3/5 TRIO/QUAD; SURGICAL LIGHT

Model Number	4028310
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During a first device inspection by a field service technician no concrete malfunction or defect could be determined.A follow-up inspection was scheduled which is currently not completed.The event occurred after the repair of the locking mechanism in relation to our report (b)(4).If new relevant information will become available a follow-up report will be provided.
Event or Problem Description
The customer reported the sterile handle detached during a surgical procedure from the light head and landed on the patients legs.No injury was reported in relation to this allegation.This report was filed in our complaint handling system as complaint # (b)(4).
Event or Problem Description
The customer reported the sterile handle detached during a surgical procedure from the light head and landed on the patients legs.No injury was reported in relation to this allegation.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
During device inspection it was determined that the locking pin at the locking mechanism was not correctly adjusted allowing the sterile handle to detach.The root cause was traced to an installation/adjustment failure during the repair at the previous service event.The locking mechanism (locking pin) was adjusted and the device function checked.Based on the investigation results no further action is required.

• Brand Name: ILED 3/5 TRIO/QUAD
• Common Device Name: SURGICAL LIGHT
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; 7-9 carl-zeiss-strasse; saalfeld 07318 ; GM 07318
• MDR Report Key: 11782629
• Report Number: 9681407-2021-00015
• Device Sequence Number: 3481222
• Product Code: FSY
• UDI-Device Identifier: 00887761995949
• UDI-Public: 887761995949
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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
• Operator of Device: No Information
• Device Model Number: 4028310
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1