MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED7; SURGICAL LIGHT

Model Number 4047020

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the sterile handle fell into the sterile field during surgery.No further information is available on the repair of the surgical light/handles at this time.The investigation is ongoing.Any additional relevant information identified following completion of the investigation will be submitted in a supplemental report.

Event Description

The customer alleged a sterile handle from the company aspen surgical was attached to the iled 7 light head.The handle detached and fell into the sterile field during surgery.No patient, or caregiver injury was reported.This report was filed in our complaint handling system as complaint#: (b)(4).

Event Description

The customer alleged a sterile handle from the company aspen surgical was attached to the iled 7 light head.The handle detached and fell into the sterile field during surgery.No patient or caregiver injury was reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

Hillrom/trumpf medical investigated the event and relevant parts of the affected device.No malfunction or deviation from the specification was identified.A test with a hillrom/trumpf medical sterile handle passed, it was not able to detach the handle without pressing the release button.However, the involved aspen medical sterile handle was not available for investigation.As a conclusion, the hillrom/trumpf medical device did not cause or contribute to the event.The most likely root cause was identified to be the aspen medical sterile handle.Aspen medical was notified about the complaints.According to the ifu the customer is responsible to ensure to have a compatibility declaration is case other manufacturers sterile handles are used at hillrom/trumpf medical light heads.Hillrom/trumpf medical allows only the used of hillrom/trumpf medical handles per the ifu.

• Brand Name: ILED7
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss strasse 7-9; saalfeld 07318 ; GM 07318
• MDR Report Key: 10677839
• MDR Text Key: 211334470
• Report Number: 9681407-2020-00058
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 4047020
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1