MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH EQUIPLITE SU MTL BLADE MAC 4; LARYNGOSCOPE, RIGID

Model Number	IPN048401
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported ""happened during intubations.During the intubation of the patient, the light stopped or blinked which led to increase the difficulty of the intubation".No patient injury or harm reported.Patient condition is unknown at the time of report.
Additional Manufacturer Narrative
Qn# (b)(4).The sample was received and returned to the manufacturing site for evaluation.The manufacturing site reports during the investigation "we have conducted the functional trails on blade and handle to confirm the light flickering, but we haven't noticed any lighting issue or light flickering issue of blade.Blade was working fine, even light was glowing constantly and perfectly." the manufacturer also reports that this product family is inspected 100% prior to shipment so it is confirmed that the device left the manufacturing site fully functional.The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.Based on the investigation performed, the complaint could not be confirmed.No issues were found during functional testing of the returned sample.The device met manufacturing release specification.
Event or Problem Description
It was reported ""happened during intubations.During the intubation of the patient, the light stopped or blinked which led to increase the difficulty of the intubation".No patient injury or harm reported.Patient condition is unknown at the time of report.

• Brand Name: RUSCH EQUIPLITE SU MTL BLADE MAC 4
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11347964
• Report Number: 8030121-2021-00004
• Device Sequence Number: 14312668
• Product Code: CCW
• UDI-Device Identifier: 14026704626325
• UDI-Public: 14026704626325
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2021

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: No Information
• Device Model Number: IPN048401
• Device Catalogue Number: 004651004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 01/31/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED; NONE REPORTED