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	03/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the light of the handles always starts to flicker during intubation, so the handle had to be changed again and again.After use, the handle was checked and the batteries removed.The first battery inserted into product was deformed on behalf of the product, which was not the case before insertion of the battery into the handle".No patient injury or harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4), the sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports: "we inspected the complaint device and found that the bottom cap of the complaint device was loose and not tightened properly that could be contribute for light flickering of handles and blades.During functional testing of complaint device, it was identified that the bottom cap of the handle was in loose condition and not mounted properly, so firstly we tightened the bottom cap properly and performed the testing of handle and blade, and we have observed that complaint sample was working fine and light from the blade was constant and blowing perfectly.The device history record for lot code 190101 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The root cause of this complaint is deemed an unintentional user-related error because in the investigation it has been identified that the user had not tightened the bottom cap of the handle properly, therefore the customer had countered the light flickering issue of the handle.".
Event or Problem Description
It was reported that "the light of the handles always starts to flicker during intubation, so the handle had to be changed again and again.After use, the handle was checked and the batteries removed.The first battery inserted into product was deformed on behalf of the product, which was not the case before insertion of the battery into the handle".No patient injury or harm reported.Patient condition reported as "fine".

• Brand Name: RUSCH GREENLED HANDLE: MEDIUM
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TRUPHATEK INTERNATIONAL LTD.; 14 benny gaon street; p.o. 8051; netanya 42504 43; IS 4250443
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 13846495
• Report Number: 8030121-2022-00009
• Device Sequence Number: 11795292
• 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: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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 Model Number: IPN048573
• Device Catalogue Number: 133300
• Device Lot Number: 190101
• 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: 03/02/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 03/22/2022
• Supplement Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown