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

Model Number	IPN025485
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).The device has not been returned for investigation.
Event or Problem Description
Metal shavings/soldering flaking off the inside of the scope and fell inside the patient.
Event or Problem Description
Metal shavings/soldering flaking off the inside of the scope and fell inside the patient.
Additional 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
• Common Device Name: 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
• Report Number: 3011137372-2022-00079
• Device Sequence Number: 20086002
• Product Code: CCW
• UDI-Device Identifier: 04026704612796
• UDI-Public: 04026704612796
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Male