MAUDE Adverse Event Report: 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	09/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
Customer reported 4 broken blades from the same lot.No patient involvement reported.
Event or Problem Description
Customer reported 4 broken blades from the same lot.No patient involement reported.
Additional Manufacturer Narrative
(b)(4).The customer returned one 004551004 rusch greenlite disposable metal mac 4 blade outside of its packaging for evaluation.Visual inspection of the blade revealed the fiberoptic light guide was broken near the handle base.The returned blade was connected to a lab inventory rusch handle.The light was able to turn on but was not able to transfer through the fiberoptic light guide.The device history record of lot 2010341 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The rusch greenlite instructions for use (ifu) states, "do not sterilize or autoclave.This product is not suitable for an mri environment.Do not use if individual unit has been opened or damaged.Only personnel adequately trained to perform tracheal intubation should use laryngoscopes." the reported complaint of a broken blade prior to use is confirmed.The sample was returned with no signs of use.The light guide had completely separated from the handle base.Based on the damage observed, the root cause was determined to be packaging.A capa was initiated for an increase in greenlite breakage complaints.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: RUSCH GREENLITE DISP MTL MAC 4
• Common Device Name: LARYNGOSCOPE, RIGID
• MDR Report Key: 12579852
• Report Number: 8030121-2021-00029
• Device Sequence Number: 5936960
• Product Code: CCW
• UDI-Device Identifier: 14026734626074
• UDI-Public: 14026734626074
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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
• Operator of Device: No Information
• Device Expiration Date: 09/01/2025
• Device Model Number: IPN048386
• Device Catalogue Number: 004551004
• Device Lot Number: 2010341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 10/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2020
• 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