MAUDE Adverse Event Report: PELTON & CRANE HELIOS 3000 WALL MOUNTED LIGHT; DENTAL OPERATING LIGHT

Model Number HL3WL

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2014

Event Type  malfunction  

Event Description

It was reported that a dental professional was moving a pelton and crane helios 3000 dental light away after use when the arm assembly broke causing the light to fall down towards the ground.The light grazed the patient on the side of their head; however, the patient was not injured.

Manufacturer Narrative

Upon evaluation of the light arm rear knuckle assembly, it was observed that a portion of the knuckle had broken off the main knuckle assembly.The fracture of the knuckle started where the rotational stop pin is located.The rotational stop pin is designed to prevent the operator from rotating the light more than 360 degrees during use.It was also observed that the rotational stop pin was missing.The round counter bore hole where the stop pin is located was deformed in an oblong shape.This is indicative of force being applied to the rotational stop pin as the direction of the deformation was towards the section of the knuckle casting that had broken off.As a result, the rotational stop pin was exposed to an excessive force during use causing the failure of the knuckle assembly.

• Brand Name: HELIOS 3000 WALL MOUNTED LIGHT
• Type of Device: DENTAL OPERATING LIGHT
• Manufacturer (Section D): PELTON & CRANE; 11727 fruehauf dr.; charlotte NC 28273
• Manufacturer Contact: frank ray, manager ; 11727 fruehauf dr.; charlotte, NC 28273 ; 7045877227
• MDR Report Key: 4307650
• MDR Text Key: 5211191
• Report Number: 1017522-2014-00015
• Device Sequence Number: 1
• Product Code: EAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL3WL
• Device Catalogue Number: HL3WL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2010
• 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
• Patient Age: 72 YR