MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 4; LARYNGOSCOPE, RIGID

Model Number	IPN048387
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "incident happened in the anaesthesia department.While snapping the blade to the laryngoscope handle, the plastic part broke into several pieces at the level of the connector".No patient involvement reported.
Event or Problem Description
It was reported that: "incident happened in the anaesthesia department.While snapping the blade to the laryngoscope handle, the plastic part broke into several pieces at the level of the connector".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).The manufacturing site reports: "the actual complaint sample was not delivered to the site to perform the investigation, but the customer has provided the picture of the complaint device, which is enough to confirm the defect.The complaint sample picture was visually inspected by the chandigarh investigating team and the customer reported failure mode was verified and confirmed, i.E., the plastic part broke into several pieces at connector level." the device history record for lot code 210811341 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.Manufacturer conclusion: "the complaint of a light guide breakage in rusch greenlite mac 4 product was confirmed by the complaint investigation team.Small broken pieces of the light guide are observed in the received complaint sample picture.The product was manufactured at the chandigarh site in aug 2021.The product was manufactured and packed in india.We inspect this product family 300% prior to shipment from india, so we can state that it left the manufacturing site fully functional.The root cause of this complaint is deemed packaging related.".

• Brand Name: RUSCH GREENLITE DISP MTL MAC 4
• 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: 13514991
• Report Number: 8030121-2022-00006
• Device Sequence Number: 11880513
• Product Code: CCW
• UDI-Device Identifier: 14026737626088
• UDI-Public: 14026737626088
• 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): 01/21/2022

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: 08/10/2026
• Device Model Number: IPN048387
• Device Catalogue Number: 004551004
• Device Lot Number: 210811341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• 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: HANDLE; HANDLE
• Patient Sex: Unknown