MAUDE Adverse Event Report: TELEFLEX MEDICAL PILLING DEDO-STYLE LASER LARYNGOSCOPE; LARYNGOSCOPE, RIGID

Catalog Number 522221

Device Problem Flaked (1246)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

The report states: this is a custom item of the dedo - pc12-04013.The doctor states that during a vocal cord procedure yesterday she noticed the patient had metal shavings coming off the laryngoscope.The shavings were able to be suctioned out and no patient injury occurred.Patient is a professional singer; the surgeon stated that there may be some emotional trauma associated with the idea of these shavings.

Manufacturer Narrative

Qn# (b)(4).No dhr was conducted due to this is a custom device.(1) sample of 522221 was received for evaluation.The returned sample is marked as a "custom" with serial number (b)(6).As a customer device, this should have been sent to the manufacturer for investigation.The returned sample is approximately 8 years old and exhibits degradation of the solder channels along the exterior of the scope.Due to the age of the device it is impossible to ascertain the contributing factors which may have led to the solder degrading.As a custom device the owner assumes responsibility for method of use and appropriate cleaning.The device can be serviced back to like new condition at the manufacturing facility if service is desired.We do not have design responsibility for this device.No further investigation is required.

Event Description

The report states: this is a custom item of the dedo - (b)(4).The doctor states that during a vocal cord procedure yesterday she noticed the patient had metal shavings coming off the laryngoscope.The shavings were able to be suctioned out and no patient injury occurred.Patient is a professional singer; the surgeon stated that there may be some emotional trauma associated with the idea of these shavings.

• Brand Name: PILLING DEDO-STYLE LASER LARYNGOSCOPE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10163195
• MDR Text Key: 195555649
• Report Number: 3011137372-2020-00144
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

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 Catalogue Number: 522221
• Device Lot Number: PC12-04013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 06/17/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1