MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLED HANDLE: MEDIUM; LARYNGOSCOPE, RIGID

Model Number	IPN915489
Medical Device Problem Code	Intermittent Continuity (1121)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the light was flickering prior to use.".
Additional Manufacturer Narrative
Qn#(b)(4) the actual device was returned by the customer and sent to the manufacturing site for evaluation.The manufacturing site reports: the visual examination revealed that the locking mechanism (groove area) was deformed and damaged, and the groove was worn out.These marks reveal that the device has been used multiple times by the end user, and they are indicative of increased wear or groove is worn out.The functional inspection was performed per laryngoscope handle ifu by pushing downward on the blade to release it from the handle.The blade and handles were reattached and disassembled multiple times, and it was noted that there is light flickering as reported in the complaint.The complaint cannot be confirmed because there were deep scratch marks noted on the internal locking mechanism of the handle, and the locking mechanism was found to be damaged.These marks reveal that the device has been used multiple ti mes by the end user, and they are indicative of increased wear, and the groove is worn out.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.Manufacturer conclusion: based on the functional testing performed on the device it is found that the root cause is related to unintentional user error.The ifu for this product states "always inspect the devices for damage or increased wear.Do not re-use damaged or worn devices." teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that "the light was flickering prior to use." no patient involvement.

• Brand Name: RUSCH GREENLED HANDLE: MEDIUM
• 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: 16629170
• Report Number: 8030121-2023-00009
• Device Sequence Number: 5324260
• Product Code: CCW
• UDI-Device Identifier: 14026704711694
• UDI-Public: 14026704711694
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2023

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: Health Professional
• Device Model Number: IPN915489
• Device Catalogue Number: 133300
• Device Lot Number: 200901
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown