MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED 7 CEILING TRIO; SURGICAL LIGHT

Model Number 4068310

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2022

Event Type  malfunction  

Event Description

The customer reported the plate with vesa monitor adapter and handpiece holder fell during clinical activity which is part of the monitor holder adapter from the company cim.No harm or impact to a surgical procedure was reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

Inspection of the device is pending.Further investigation should confirm the root cause.Investigation results will be provided within a final report if new information will become available.

Manufacturer Narrative

The alleged event was investigated by trumpf medical/hillrom and the supplier of the monitor holder, cim med.During a review of the provided information from our italian distributor (altamed) as well as the returned monitor holder the following conclusion was made: according to the condition of the monitor holder it is not likely that the product was installed and in use.There was no signs of use or wear and parts were still secured by the original packaging.The initial allegation ¿monitor adapter and handpiece holder fell during clinical activity¿ could not be confirmed.The damages found are based on a fall of the equipment from approximately 70 cm, but an event could not have occurred during use or clinical activity.Further questions for the duration of clinical use (which was alleged) were not answered by the distributor/customer.Based on these findings no further actions are necessary.

Event Description

The customer reported the plate with vesa monitor adapter and handpiece holder fell during clinical activity which is part of the monitor holder adapter from the company cim.No harm or impact to a surgical procedure was reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: ILED 7 CEILING TRIO
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; 7-9 carl zeiss strasse; saalfeld 07318 ; GM 07318
• Manufacturer Contact: frances coote ; 7-9 carl zeiss strasse; saalfeld 07318 ; GM 07318
• MDR Report Key: 15507924
• MDR Text Key: 306335648
• Report Number: 9681407-2022-00022
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00887761995840
• UDI-Public: 887761995840
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4068310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1