MAUDE Adverse Event Report: VERATHON MEDICAL ULC TITANIUM LOPRO T4; LARYNGOSCOPE, RIGID

Model Number 0574-0127

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2017

Event Type  malfunction  

Manufacturer Narrative

This is an initial report and the product has not yet been received for evaluation.Should the device be returned, the device evaluation data will be included in a follow-up report.

Event Description

The customer reported that during inspection of the titanium lopro t4, the biomed noted that the blade had a sharp edge near the camera.No delay in the procedure or use of a back-up device was reported.No harm to patient or user was reported.

Manufacturer Narrative

The device was received by verathon technical services on february 16, 2017 and via a visual inspection, as alleged in the initial complaint, there appeared to be a sharp edge next to camera.The device was sent to (b)(4) for a technical review which was performed march 20, 2017.During the technical review, damage was observed along the edge of the blade near the camera so the edge was tested for sharpness in accordance with the set-50 edge sharpness testing procedure.It was found that the edge is not considered sharp.It was noted that the damage found along the edge of the blade is not typical of the casting process and therefore likely occurred sometime after it was received from the manufacturer.

• Brand Name: TITANIUM LOPRO T4
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, bc V5C 5 A9; CA V5C 5A9
• Manufacturer Contact: kent huthsing ; 20001 north creek pkwy; bothell, WA 98011-8218 ; 4258671348
• MDR Report Key: 6349001
• MDR Text Key: 67952693
• Report Number: 9615393-2017-00034
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0574-0127
• Device Catalogue Number: 0574-0148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1