MAUDE Adverse Event Report: VERATHON MEDICAL ULC. GLIDESCOPE GVL 5; VIDEO LARYNGOSCOPE

Model Number GLIDESCOPE GVL 5

Device Problem Material Frayed (1262)

Patient Problem Injury (2348)

Event Date 06/01/2015

Event Type  Injury  

Event Description

During intubation using the glidescope gvl 5, a patient was injured due to a sharp edge on the tip of the blade.The patient was fine after the procedure.

Manufacturer Narrative

Device evaluation summary: this product has not been received back for evaluation at the time of this report.The problem cannot be confirmed.If the suspect device is being returned and a supplemental report will be issued with the results of the evaluation.On 05/10/2013 safety alert notice c/r 3022472-5-07-2013-0001-c was issued to all customers to provide additional safety information to remind users to carefully examine blades before and after each use, and promptly replace any that show signs of wear or damage.

Manufacturer Narrative

Device evaluation summary: the returned device was evaluated and our technician could not confirm any sharp edges on the device.The blade was found to have delamination, a missing sealing cap, and the plastic plate on top of the serial number was damaged.On 5/10/2013 safety alert notice c/r 3022472-5-07-2013-0001-c was issued to all customers to provide additional safety information to remind users to carefully examine blades before and after each use, and promptly replace any that show signs of wear or damage.

• Brand Name: GLIDESCOPE GVL 5
• Type of Device: VIDEO LARYNGOSCOPE
• Manufacturer (Section D): VERATHON MEDICAL ULC.; burnaby, bc ; CA
• Manufacturer Contact: brian anderson ; 20001 north creek pkwy.; bothell, WA 98011 ; 8003312313
• MDR Report Key: 4930979
• MDR Text Key: 6013860
• Report Number: 9615393-2015-00060
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: GLIDESCOPE GVL 5
• Device Catalogue Number: 0574-0030
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2009
• 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
• Patient Outcome(s): Required Intervention