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

Model Number IPN025485

Device Problem Material Separation (1562)

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

Event Date 04/27/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).The device has not been returned for investigation.

Event Description

Metal shavings/soldering flaking off the inside of the scope and fell inside the patient.

Event Description

Metal shavings/soldering flaking off the inside of the scope and fell inside the patient.

Manufacturer Narrative

Qn#(b)(4).Device history record could not be conducted.Custom device.(1) sample of 522221 lot # pc12-04755 was received for evaluation.No visual concerns were noted.The accessory ports were visual inspected.The root cause of the metal shavings could not be determined.This is a custom device as indicated by the pc lot number.The surgeon owns design responsibility for a custom device and is beyond our purview.The vendor has reviewed the custom devices and was unable to determine a root cause.The samples have been cleaned and returned to the customer.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14349138
• MDR Text Key: 291351504
• Report Number: 3011137372-2022-00079
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 04026704612796
• UDI-Public: 04026704612796
• 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,Followup
• Report Date: 04/28/2022

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 Model Number: IPN025485
• Device Catalogue Number: 522221
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/10/2022
• Supplement Dates Manufacturer Received: 06/22/2022
• Supplement Dates FDA Received: 06/23/2022
• 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
• Patient Sex: Male