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	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During device inspection by a field service technician it was identified that a plastic part of the locking mechanism was broken which caused the locking mechanism to not correctly lock into the sterile handle.The defect part was exchanged and the device function checked.If new relevant information will become available a follow-up report will be provided.
Event or Problem Description
The customer reported the locking mechanism for the sterile handle is broken.During device inspection by a field service technician the customer reported that the sterile handle did fell off several times in the past, one time it fell onto the hand of an or staff member.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
The root cause for the broken plastic part was determined to an excessive mechanical impact which is not likely to occur during the intended use.It could not be identified which impact occurred.Based on the investigation results no further action is required.
Event or Problem Description
The customer reported the locking mechanism for the sterile handle is broken.During device inspection by a field service technician the customer reported that the sterile handle did fell off several times in the past, one time it fell onto the hand of an or staff member.No injury was reported in relation to this allegation.This report was filed in our complaint handling system as complaint # (b)(4).

• 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: 11782626
• Report Number: 9681407-2021-00014
• Device Sequence Number: 3481221
• 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: 04/08/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• 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