MAUDE Adverse Event Report: AMERICAN DIAGNOSTIC CORPORATION SATIN¿ DISPOSABLE LARYNGOSCOPE HANDLE

Model Number	4065D-20
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	08/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Adc received a report from a distributor on (b)(6) 2018 relating to a disposable spu laryngoscope handle.Complainant indicated that end user facility was using the product in an emergency situation and that the disposable blade and handle did not connect properly.The patient was handled with an alternate procedure and had a positive outcome.The complainant was able to connect with the end user facility to return the device to adc for evaluation.This device was returned to adc on 9/5/2018.It was determined that the product was from lot 18020011 and that the product was in used condition.Evaluation of the initial product showed that the laryngoscope blade and handle would connect and provide illumination, but application of pressure to the blade, such as might be experienced during intubation, would result in the light flickering and becoming unreliable.After evaluation it was determined that the cause of the light issue was the handle (part number 4065d-20) and not the spu blades as the blades were functional with other handles and functional blades from alternate products did not work properly on this specific laryngoscope handle.It appears that the light source on the product is recessed slightly, resulting in poor connection with the handle.As soon as the initial complaint was received, adc tested (b)(4) pieces of stock to check for light fluctuations.All stock was found to be conforming to specifications and working as intended.Upon receipt of the device involved in the complaint the device's specific lot was also sampled, with another (b)(4) pieces from lot 18020011 being tested.Testing consisted of affixing spu laryngoscope blades to the 4065d-20 handles and applying pressure to the blade to confirm light functionality.Several pieces were tested in destructive tests to breaking point with excessive force (more force than would be present during intubation) being applied.All product tested worked as intended with no light fluctuations.The original (b)(4) pieces that had been sampled were retested with pressure applied to the blades and these also passed inspection.With (b)(4) pieces tested, this is greater than an s4 sampling size under the ansi z1.4 standard given current stock quantities.Based on our evaluation of stock, our product line does not appear to contain a quality defect and this specific lot of product also appears to be free of product defects.We have concluded that this issue was isolated to the device involved in the complaint and that it is unlikely to recur in the field.
Event or Problem Description
Difficult intubation.Handle would not make metallic contact with light source.

• Brand Name: SATIN¿ DISPOSABLE LARYNGOSCOPE HANDLE
• Common Device Name: LARYNGOSCOPE HANDLE
• Manufacturer (Section D): AMERICAN DIAGNOSTIC CORPORATION; 55 commerce drive; hauppauge NY 11788
• MDR Report Key: 7856049
• Report Number: 2434008-2018-00001
• Device Sequence Number: 1566985
• Product Code: CCW
• UDI-Device Identifier: 00634782063610
• UDI-Public: 00634782063610
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 09/07/2018

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: 4065D-20
• Device Catalogue Number: 4065D-20
• Device Lot Number: 18020011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other