MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 3; LARYNGOSCOPE, RIGID

Model Number	IPN915459
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "during a laryngoscopy into the patient, a slight unusual noise was heard from the blade.The light from the blade was less bright so it made the intubation more difficult to perform.Nevertheless there was no consequence for the patient.When checking after the laryngoscopy procedure (outside the patient), one part of the blade was cracked and then broke".No patient injury or harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).The actual device was returned and sent to the manufacturing site for evaluation.The manufacturing site reports: "the complaint sample was visually inspected by the chandigarh investigating team and the customer reported failure mode was verified and confirmed, i.E., the light pipe was broken as stated in the complaint notification.While performing the visual inspection, we have observed that there were heavy scratch marks on the complaint blade as shown in below picture and it seems that these scratches were developed on the complaint blade due to the handle which was involved in the incident because there might be possibilities that either the groove of the handle was damaged or the groove was worn out which can cause to lighting issue of blade and also can contribute for scratch generation on the blade surface." the manufacturer also reports: "we did perform the functional testing of the defective complaint sample for light out and engagement/dis-engagement with the lab greenled fo handle and it has been observed that light out was sufficient and blade was illuminating perfectly, and we haven't observed any light output difficulties with complaint device.Further we did the simulation trail to replicate the light guide breakage by using the deform groove of handle.In the simulation trial, we can see that if the handle groove is worn/damaged, then there is an impact on the light guide and the light guide is breaking when the groove is damaged." the device history record for lot code 2107331 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.Manufacturer's conclusion: "the possible cause of the light guide breakage in the customer return blade might be due to the handle groove that may be damaged/worn out, which results from the actual root cause as undetermined because we didn't receive the actually involved handle from the customer.Moreover, based on the dimensional inspection and functional testing of the complaint sample, the product meets all manufacturing release specifications.For further investigation, we required the user handle on which this failure of the product has occurred.".
Event or Problem Description
It was reported that: "during a laryngoscopy into the patient, a slight unusual noise was heard from the blade.The light from the blade was less bright so it made the intubation more difficult to perform.Nevertheless there was no consequence for the patient.When checking after the laryngoscopy procedure (outside the patient), one part of the blade was cracked and then broke".No patient injury or harm reported.Patient condition reported as "fine".

• Brand Name: RUSCH GREENLITE DISP MTL MAC 3
• 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: 13446716
• Report Number: 8030121-2022-00003
• Device Sequence Number: 4304675
• Product Code: CCW
• UDI-Device Identifier: 14026734626074
• UDI-Public: 14026734626074
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2022

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 Expiration Date: 06/15/2026
• Device Model Number: IPN915459
• Device Catalogue Number: 004551003
• Device Lot Number: 2107331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2022
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 03/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown