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

Model Number	IPN048386
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during intubation a small part of the fiber optic falls down into the esophagus".Additional information received stated that "it has been removed after the gastroscope procedure".No patient harm or injury reported.Patient condition reported as "fine".
Event or Problem Description
It was reported that "during intubation a small part of the fiber optic falls down into the esophagus".Additional information received stated that "it has been removed after the gastroscopie procedure".No patient harm or injury reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(6) 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." in addition it was reported "visual inspection result showed, the spot-welding joint was intact in complaint device and there was deep scratch mark discovered on the complaint device, it seems that the observed defect of scratch mark on the complaint sample is suspected and might be due to mishandling of product during use, or the product was potentially contacted with an embossed surface which resulted in the scratch generation on blade profile.Further we did perform the dimensional inspection of the customer returned complaint sample for critical dimensions which could contribute for light guide breakage and for product functionality.As per the dimensional inspection results of complaint sample, defective product was found acceptable for critical dimensions as per design/drawing and manufacturing release specifications." the device hi story record for lot code 2104331 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 complaint of a light guide breakage in rusch green lite mac 3 product during use was confirmed by the chandigarh complaint investigation team.The light pipe of the blade broke at the pipe side during intubation, as stated in the complaint summary (which pulls the light).The product was manufactured and packed at the chandigarh site in april 2021.We inspect this product family 300% prior to shipment from india, so we can state that it left the manufacturing site fully functional.Although we received the additional information from customer where customer confirmed that he did not notice or hear any abnormal or crack sound of light guide during intubation, so it could be possible that light guide was already broken before use.Even visual inspection results showed, the spot-welding joint was intact in the complaint device and there was deep scratch mark discovered on the complaint device, it seems that the observed defect of scratch mark on the complaint sample is suspected and might be due to mishandling of the product during use, or the product was potentially contacted with an embossed surface which resulted in the scratch generation on blade profile, but there is no objective evidence of such information which states that the product was mishandled, but a scratch on blade profile shows product potentially had come in contact with embossed surface.Since the light pipe was broken during use and medical intervention was performed to retrieve the plastic part, with these facts this complaint is considered justified.".

• 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: 13667367
• Report Number: 8030121-2022-00007
• Device Sequence Number: 5303194
• Product Code: CCW
• UDI-Device Identifier: 14026734626074
• UDI-Public: 14026734626074
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 02/08/2022

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: 04/15/2026
• Device Model Number: IPN048386
• Device Catalogue Number: 004551003
• Device Lot Number: 2104331
• 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: 02/08/2022
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown