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

Catalog Number 522221

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2022

Event Type  malfunction  

Event Description

This was a custom made 522221-low-profile dedo laryngoscope.Soldering flakes from inside scope flaking off into the surgical site.The doctor remove all the debris.

Manufacturer Narrative

(b)(4).A visual inspection of the device cannot be provided as the device was returned to the manufacturer for review.The manufacturer was unable to determine the source of the flaking.The sample was cleaned and returned to the customer.A dimensional inspection was not required as part of this investigation.A functional inspection was not required as part of this investigation.This is a custom version of the 522221 which exists outside the tfx qms.Root cause unknown and linked to parts or tools that made contact with the device.A visual inspection of the device cannot be provided as the device was returned to the manufacturer for review.The manufacturer was unable to determine the source of the flaking.The sample was cleaned and returned to the customer.A dimensional inspection was not required as part of this investigation.A functional inspection was not required as part of this investigation.4 complaints including this one, have been logged for flaking of a custom version of 522221.2 additional complaints were received from the same customer.1 previous instance in 2020 was also noted.This is a custom version of the 522221 which exists outside the tfx qms.Root cause unknown and linked to parts or tools that made contact with the device.The manufacturer's investigation is as follows: as these are custom parts they are normally outside the scope of the qms.At this time we do not know why the parts flaked, as we do not know how the parts were used and what other tools came in contact with the parts.As a courtesy to the customer clean all three (3) returned scopes with no charges.No corrective action - custom parts are not part of the qms.

• Brand Name: PILLING DEDO-STYLE LASER LARYNGOSCOPE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 14959351
• MDR Text Key: 303717896
• Report Number: 3011137372-2022-00131
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2022

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1