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

Catalog Number 83171

Device Problem Mechanical Problem (1384)

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

Event Date 05/23/2019

Event Type  malfunction  

Event Description

It was reported, "the back cover of the light fell off" in or 34.There were no reported injuries.The light is within scope of field action res 83355.

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), and capa (b)(4) were opened to review and address this issue.This light is within scope of the field action.

• Brand Name: LIGHTHEAD F628
• 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: 16268701
• MDR Text Key: 309152468
• Report Number: 0008010153-2023-00002
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• 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: 83171
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 01/30/2023
• 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
• Removal/Correction Number: RES 83355
• Patient Sequence Number: 1