MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG SPRING ARM, D 300; AC-POWERED MEDICAL EXAMINATION LIGHT

Catalog Number 83625

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

It was reported that the d300 examination light head allegedly fell.A stryker field service technician (sfst) was dispatched for investigation.Upon arrival, the sfst found that the screws and metal tension strips were floating around inside the light.The sfst stated that the light did not appear to have suffered impact from any other equipment.There was no injury or adverse consequence reported.The investigation into the cause of the fall is ongoing and a supplemental will be filed upon completion.

Event Description

It was reported that the d300 light head allegedly fell.There was no injury or adverse consequence reported.

Manufacturer Narrative

It was reported that the d300 examination light head allegedly fell.A stryker field service technician (sfst) was dispatched for investigation.Upon arrival, the sfst found that the screws and metal tension strips were floating around inside the light.The sfst stated that the light did not appear to have suffered impact from any other equipment, but a few months prior to the light head reportedly falling, a damaged cover on the unit was replaced.Based on additional comments from the technician and a review of the photo provided by the sfst the light head appears to have been pulled with extreme force, which is not how the light is intended to be used.It is believed that over the 10 years this light head was in use by the account, there was misuse involved, causing the internal structural components to break.There was no injury or adverse consequence reported.

Event Description

It was reported that the d300 light head allegedly fell.There was no injury or adverse consequence reported.

• Brand Name: SPRING ARM, D 300
• Type of Device: AC-POWERED MEDICAL EXAMINATION 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: 6204717
• MDR Text Key: 63631923
• Report Number: 0008010153-2016-00109
• Device Sequence Number: 1
• Product Code: KZF
• 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,Followup
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 83625
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2016
• 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