MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG LIGHT HEAD F 528 WITH COLOR SELECT AND GUIDELITE; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number CY 1005528

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the blue circular dome on the back of the f gen light head fell; there were no reported injuries or adverse consequences.(b)(4) were opened to review and address this issue.This light is within scope of the field action.

Event Description

It was reported that the blue dome on scialytic cover fell down.There were no reported injuries.This light is within scope of the field action res (b)(4).

• Brand Name: LIGHT HEAD F 528 WITH COLOR SELECT AND GUIDELITE
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: volker hornscheidt ; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532 ; 74611810
• MDR Report Key: 16268731
• MDR Text Key: 309134490
• Report Number: 0008010153-2023-00003
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CY 1005528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: RES 83355
• Patient Sequence Number: 1