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

Model Number IPN915489

Device Problem Intermittent Continuity (1121)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the light was flickering prior to use.".

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 Description

It was reported that "the light was flickering prior to use." no patient involvement.

• Brand Name: RUSCH GREENLED HANDLE: MEDIUM
• Type of Device: 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
• MDR Text Key: 312411168
• Report Number: 8030121-2023-00009
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704711694
• UDI-Public: 14026704711694
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 05/09/2023
• Supplement Dates FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1