MAUDE Adverse Event Report: PANORAMIC CORP. PANORAMIC X-RAY MODEL LASER-1000; PC-1000/LASER1000

Model Number 800724-3

Device Problems Component Falling (1105); Nonstandard Device (1420); Sticking (1597); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem Contusion (1787)

Event Date 12/28/2004

Event Type  Injury  

Event Description

Machine was making noises going up and down for two weeks prior to event as well as getting stuck.Machine fell and struck a dental assistant's foot.Dental tech got checked out and had a contusion on the big toe.

Manufacturer Narrative

A recall for this issue was initiated on 4/23/2015.

• Brand Name: PANORAMIC X-RAY MODEL LASER-1000
• Type of Device: PC-1000/LASER1000
• Manufacturer (Section D): PANORAMIC CORP.; fort wayne IN
• Manufacturer Contact: 4321 goshen rd.; fort wayne, IN 46818 ; 8006542027
• MDR Report Key: 4881455
• MDR Text Key: 5865912
• Report Number: 1832462-2015-00049
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 800724-3
• Device Lot Number: 6000-13885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2004
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2001
• 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 Outcome(s): Other