MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG F628/F628 SURGICAL LIGHT; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number FD 2000

Device Problems Misassembled (1398); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 09/16/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that a surgical light fell and that a nurse caught the light.When the stryker field service technician (sfst) arrived onsite to replace the light, the customer requested that the sfst inspect the other lights that were converted to low ceiling at the same time.Upon inspection, the sfst found that the c-clip was not found to be installed in the other lights.The sfst installed the c-clip and the sfst checked for functionality.  there was no patient  involvement and no adverse event reported to have occurred.

Event Description

It was reported that a surgical light fell and that a nurse caught the light.When the stryker field service technician (sfst) arrived onsite to replace the light, the customer requested that the sfst inspect the other lights that were converted to low ceiling at the same time.Upon inspection, the sfst found that the circlip was not found to be installed in the other lights.There was no patient involvement and no adverse event reported to have occurred.

• Brand Name: F628/F628 SURGICAL LIGHT
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• 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: 6918251
• MDR Text Key: 89472024
• Report Number: 0008010153-2017-00034
• 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: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FD 2000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2017
• 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