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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE VIDEO BATON 2.0 LARGE; LARYNGOSCOPE, RIGID

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VERATHON MEDICAL ULC GLIDESCOPE VIDEO BATON 2.0 LARGE; LARYNGOSCOPE, RIGID Back to Search Results
Model Number 0570-0382
Device Problems Erratic or Intermittent Display (1182); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/11/2021
Event Type  malfunction  
Manufacturer Narrative
The device return is anticipated, however; at the time of the report the devices have not been received by verathon.
 
Event Description
The customer reported that during a patient procedure, using a glidescope video baton 2.0 large, the connection between the baton and the smart cable was intermittently loose and causing the picture to go in and out.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.
 
Manufacturer Narrative
A replacement glidescope video baton 2.0 large was provided to the customer and the video baton 2.0 large used in the procedure was returned to verathon for evaluation.A verathon technical service representative evaluated the returned video baton 2.0 and was unable to confirm the baton's loose connection to a known, good, test smart cable.Technical service representative connected the customer's video baton 2.0 into test equipment and no image issue was found.The camera image quality test was performed and passed.A visual inspection of the connector found the hdmi connector to be damaged.Since the customer had already received a replacement video baton 2.0, the returned glidescope video baton 2.0 large was scrapped.No further investigation is required at this time.Verathon will continue to monitor for trends.The glidescope operations and maintenance manual (omm) notes that "before every use, ensure that the instrument is operating correctly and has no sign of damage.Do not use this product if the device appears damaged.".
 
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Brand Name
GLIDESCOPE VIDEO BATON 2.0 LARGE
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
VERATHON MEDICAL ULC
2227 douglas road
burnaby, british columbia V5C 5 A9
CA  V5C 5A9
MDR Report Key11446628
MDR Text Key244599179
Report Number9615393-2021-00055
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 02/12/2021
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
Device Operator Health Professional
Device Model Number0570-0382
Device Catalogue Number0570-0398
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2021
Initial Date Manufacturer Received 02/12/2021
Initial Date FDA Received03/09/2021
Supplement Dates Manufacturer Received05/03/2021
Supplement Dates FDA Received05/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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