MAUDE Adverse Event Report: AMERICAN DIAGNOSTIC CORPORATION PROSCOPE¿ 5210; OTOSCOPE AND OPHTHALMOSCOPE

Model Number	5210
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that adc's part number 5210, which is a 2.5v otoscope and ophthalmoscope, had abnormal heat when they attempted to use it and that the product caught on fire.No injuries were reported and no patient involvement.This is a handheld, battery operated device.
Additional Manufacturer Narrative
Adc received a report from our distributor that a product sold to an end user facility had presented abnormal heat and then caught fire.No injuries or patient involvement was reported.The device involved in the incident was discarded and was not provided to adc.Due to the fact that the involved device was discarded, adc has conducted tests on existing stock to identify any risks posed by the device.This device is a battery handle with detachable otoscope and ophthalmoscope head attachments.It is hand held, 2.5v and uses two c cell batteries.The device is operated with a rheostatic power control switch.To replicate the risks associated with the circuit used in the device adc has created four test samples, with one sample being a control and three samples being intentionally shorted to create heat.In addition, testing was performed using the ophthalmoscope head attachment which places the bulb in the device as close to the battery handle as possible, maximizing heat output and creating a worst case scenario.As demonstrated in the attached report, testing has shown that even in a fault or shorted condition this product cannot generate adequate heat to create ignition or present a hazard of burns or other heat-related injuries.The product will also not create adequate heat to create ignition when left on for an extended period of time beyond the normal use of the device or when left powered on it is carrying case.Historical data for this product line was evaluated and this product category has been on the market for multiple decades with no previously reported fire events or hazards.We have concluded that this event would have been caused by external factors such as an external heat source or by the use of batteries inappropriate for a 2.5v system, such a lithium ion, lithium metal, or rechargeable batteries with an inappropriate voltage for this type of device.This device is not sold with batteries included.

• Brand Name: PROSCOPE¿ 5210
• Common Device Name: OTOSCOPE AND OPHTHALMOSCOPE
• Manufacturer (Section D): AMERICAN DIAGNOSTIC CORPORATION; 55 commerce drive; hauppauge NY 11788
• Manufacturer (Section G): AMERICAN DIAGNOSTIC CORPORATION; 55 commerce drive; hauppauge NY 11788
• Manufacturer Contact: michael falco ; 55 commerce drive; hauppauge, NY 11788 ; 6312739600
• MDR Report Key: 14462996
• Report Number: 2434008-2022-00001
• Device Sequence Number: 5175746
• Product Code: HLJ
• UDI-Device Identifier: 00634782053413
• UDI-Public: (01)00634782053413
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K093495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2022

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
• Operator of Device: Health Professional
• Device Model Number: 5210
• Device Catalogue Number: 5210
• Device Lot Number: 102020354
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown