MAUDE Adverse Event Report: PANORAMIC CORPORATION PANORAMIC X-RAY MODEL PC-1000

Model Number 800724-1

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Missing Value Reason (3192)

Event Date 04/26/2016

Event Type  malfunction  

Manufacturer Narrative

Service: the service manager confirmed that there have been no other documented service calls for the screwmotor associated with this machine serial number.Field observation: on thursday 4/28/2016, a panoramic field technician removed the screwmotor assembly in the field and took some initial photos which showed the safety nut was stuck inside the safety sleeve, from these observations and pictures it was necessary to get the motor returned to panoramic for further evaluation.Returned to panoramic: 5/5/2016.Inspection of the screwmotor was done on 5/8/2016.Upon opening the box , it is noted that none of the tell-tale thread debris is visible inside the box.Photos were taken of the motor before anything was done.Power was applied to the motor assembly and the motor was working and the nut assembly was able to be moved down the shaft, so that i could access the safety sleeve mounting setscrews.The safety sleeve mounting setscrews were untightened so that the safety sleeve and safety nut could be separated from the t-nut assembly.Once these were loosened the t-nut assembly was pulled, but did not move, it was rotated and it did move.The threads inside the t-nut assembly were still intact.This motor did not fall as reported in the initial complaint.Power was again supplied to the unit and the t-nut assembly was unthreaded from the shaft.Inspection of the t-nut assembly after it was removed showed that it has all of its threads completely intact.Next the safety sleeve was removed from the shaft, damage to the sleeve was visible where the safety nut sits.Finally the safety nut was removed from the shaft, damage to the safety nut was visible on two of the corners.The t-nut assembly, safety sleeve, and the safety nut were all degreased in order to clearly view and photograph them.The t-nut assembly on motor# 9185 did not fail in this instance.It appears the safety nut became jammed and broke into the holding lip of the safety sleeve.It was this metal snapping noise that would have caused the noise heard by the office which was falsely reported as a fall.Previous observations of this phenomena demonstrate the loud popping noise that can be heard outside of the machine when the safety sleeve is broken.This audible sound alerted the operator that an issue had occurred and they contacted panoramic for service, it was incorrectly characterized as a fall and t-nut failure.This investigation concludes that machine s/n (b)(4) did not fall and at no time was anyone at risk of injury.

Event Description

Machine fell when adjusting the height of the unit.No one was in the machine.No injuries.

• Brand Name: PANORAMIC X-RAY MODEL PC-1000
• Type of Device: PC-1000
• Manufacturer (Section D): PANORAMIC CORPORATION; 4321 goshen road; fort wayne IN 46818
• Manufacturer (Section G): PANORAMIC CORPORATION; 4321 goshen road; fort wayne IN 46818
• Manufacturer Contact: tammy shiffler ; 4321 goshen road; fort wayne, IN 46818 ; 8006542027
• MDR Report Key: 5926691
• MDR Text Key: 53902410
• Report Number: 1832462-2016-00011
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K870236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Dentist
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 800724-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2006
• 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