MAUDE Adverse Event Report: BERCHTOLD CORP CARDANIC FOR D650 AC 3-POLE; SURGICAL LIGHT

Catalog Number 75216

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2016

Event Type  malfunction  

Manufacturer Narrative

It was reported that the light head allegedly fell.A stryker field service technician (sfst) was dispatched for investigation.When the sfst arrived to the customer site, the light head was disconnected from the cardanic and was laying on the surgical table.The sfst noted that the four screws that held the light head in place became loose, resulting in the separation.There was no injury or adverse consequence reported.

Event Description

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

• Brand Name: CARDANIC FOR D650 AC 3-POLE
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): BERCHTOLD CORP; 1950 hanahan road; charleston SC 29406
• Manufacturer (Section G): BERCHTOLD CORP; 1950 hanahan road; charleston SC 29406
• Manufacturer Contact: adam gorzeman ; 1950 hanahan road; charleston, SC 29406 ; 8435696100
• MDR Report Key: 6204716
• MDR Text Key: 63325855
• Report Number: 0001220865-2016-00022
• 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: 12/27/2016

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: 75216
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2016
• 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