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	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "when the user snapped the blade on the handle the clear plastic broke and disconnected from the handle".No patient injury or harm reported.Patient condition reported as "fine".
Event or Problem Description
It was reported that "when the user snapped the blade on the handle the clear plastic broke and disconnected from the handle".No patient injury or harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn#: (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Additional Manufacturer Narrative
Qn# (b)(4).The sample was received and returned to the manufacturing site for evaluation.The manufacturing site reports a visual exam was performed and small broken pieces were observed in the packaging.The spot welding joint was intact.The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The manufacturer also reports that the device is inspected prior to release thus it is confirmed that it left the manufacturing facility fully functional.It seems as though the device sustained unexplained physical damage.A root cause could not be determined.Due to an increase in complaints for breakage, a capa was opened to further investigate this issue.
Event or Problem Description
It was reported that "when the user snapped the blade on the handle the clear plastic broke and disconnected from the handle".No patient injury or harm reported.Patient condition reported as "fine".

• Brand Name: RUSCH GREENLITE DISP MTL MAC 4
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11697262
• Report Number: 8030121-2021-00016
• Device Sequence Number: 3436612
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2021

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: 11/01/2024
• Device Model Number: IPN048387
• Device Catalogue Number: 004551004
• Device Lot Number: 1912341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 05/17/2021; 07/06/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/17/2021; 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.; N/A.