MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLED HANDLE: MEDIUM; LARYNGOSCOPE, RIGID

Model Number	IPN048573
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the light flickers when the handle and blade are connected properly.It can be excluded that the fault is with the blade as the blade was tested with other rusch greenled handles and with these it worked well".
Additional Manufacturer Narrative
(b)(4), the sample was returned and sent to the manufacturer for investigation.The manufacturer reports "we have performed the functional testing of handle with blade and observed that handle is working perfectly, there is nothing abnormal with the light of blade after engagement with handle.Light was stable and glowing perfectly without any light flickering".The device history record of lot 200301 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 of the returned sample, the complaint could not be confirmed.There were no issues found during the visual exam and functional testing.The device was found to be within specification.
Event or Problem Description
It was reported "the light flickers when the handle and blade are connected properly.It can be excluded that the fault is with the blade as the blade was tested with other rusch greenled handles and with these it worked well".

• Brand Name: RUSCH GREENLED HANDLE: MEDIUM
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11558457
• Report Number: 8030121-2021-00011
• Device Sequence Number: 4204211
• Product Code: CCW
• UDI-Device Identifier: 14026704625656
• UDI-Public: 14026704625656
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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: IPN048573
• Device Catalogue Number: 133300
• Device Lot Number: 200301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 04/08/2021
• 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: BLADE; BLADE