MAUDE Adverse Event Report: VERATHON MEDICAL GLIDESCOPE CORE 15-INCH MONITOR; LARYNGOSCOPE, RIGID

Model Number	0570-0404
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device return is anticipated, however; at the time of the report the device has not been received by verathon.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
The customer reported that during a patient procedure, using a glidescope bflex 5.0 bronchoscope, the image went blank.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.
Additional Manufacturer Narrative
The customer declined to return the glidescope bflex 5.0 bronchoscope for evaluation but did return the glidescope core 15- inch monitor that was used in the procedure.A verathon technical service representative evaluated the returned core 15-inch monitor but was unable to confirm the reported "no image" issue.It was observed during testing that the video image was normal when connected to known, good, test equipment.The camera image quality test was performed and passed.Upon completion of the evaluation the glidescope core 15-inch monitor was returned to the customer.Since the glidescope bflex 5.0 bronchoscope was not returned for evaluation, a device analysis could not be completed for the bflex 5.0 bronchoscope.The device history record (dhr) and complaint history record for this lot number were reviewed with no similar complaints found.Should additional, relevant information become available, a supplemental report will be submitted in accordance with 21 cfr 803.56.No further investigation is required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE CORE 15-INCH MONITOR
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL; 20001 n creek pkwy; bothell WA 98011 8218
• MDR Report Key: 11695494
• Report Number: 9615393-2021-00111
• Device Sequence Number: 4546056
• Product Code: CCW
• UDI-Device Identifier: 00879123006332
• UDI-Public: (01)00879123006332(10)FS204500(17)211106
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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 Expiration Date: 11/06/2021
• Device Model Number: 0570-0404
• Device Catalogue Number: 0270-1033
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1