MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 4; 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	12/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "a piece of the clear plastic part broke".No patient involvement reported.
Additional Manufacturer Narrative
(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 guide was broken as stated in the complaint.The device history record for lot code 2108341 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 greenlite mac 4 product during pre-testing was confirmed by the complaint investigation team.Small broken pieces of the light guide are observed in the received complaint sample.The spot-welding joint in the sample was intact.The product was manufactured at the chandigarh site in aug 2021.The complaint sample reveals that the base of the light guide was partially broken inside the packaging and when the customer did snap the blade on the handle and the light guide was broken completely due to external force on the handle and it seems that for some reason it sustained unexplained physical damage.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.".A risk evaluation has been initiated to further investigate this issue.
Event or Problem Description
It was reported that: "a piece of the clear plastic part broke".No patient involvement reported.

• 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: 13205088
• Report Number: 8030121-2022-00002
• Device Sequence Number: 1468328
• 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): 12/20/2021

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
• Device Expiration Date: 07/01/2026
• Device Model Number: IPN048386
• Device Catalogue Number: 004551004
• Device Lot Number: 2108341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2021
• 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