MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG CHROMOPHARE OR LIGHT CEILING-MOUNTED; SURGICAL LIGHT

Catalog Number CH00000001

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that a d series light head allegedly detached from the spring arm.  a stryker field service technician (sfst) went onsite and found that the four screws that hold the light head to the cardanic were found to be backed out or broken.The sfst secured the three screws that backed out and replaced the one that was broken.Further investigation was performed and it was determined that the light has exceeded its expected lifetime.There was no patient involvement, injury or adverse consequence reported.

Event Description

It was reported that the light head allegedly detached from the spring arm.There was no patient involvement, injury or adverse consequences reported.

• Brand Name: CHROMOPHARE OR LIGHT CEILING-MOUNTED
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532
• Manufacturer (Section G): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532
• Manufacturer Contact: volker hornscheidt ; ludwigstaler strasse 25; tuttlingen 78532 ; 74611810
• MDR Report Key: 6460432
• MDR Text Key: 71728735
• Report Number: 0008010153-2017-00020
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CH00000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2017
• 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