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

Model Number IPN915489

Device Problem Continuous Firing (1123)

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

Event Date 03/10/2023

Event Type  malfunction  

Event Description

It was reported that "the light flickers prior to use.It seems as if the blade can not be fixed properly, leading to the light flickering.".

Manufacturer Narrative

Qn#(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.

Manufacturer Narrative

(b)(4).The customer returned three actual 133300 rusch greenled handle: medium for investigation.The visual examination did not reveal any obvious defects or anomalies, as the devices appear typical.There were deep scratch marks noted on the internal locking mechanism of the three handles.These marks reveal that the devices have 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 locking mechanism found to be damaged.These marks reveal that the device have been used multiple times by the end user, and they are indicative of increased wear and grove is worn out.The device history record for lot code 200601 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The root cause of this complaint is deemed related to unintentional user error related because product ifu instructions state "always inspect the devices for damage or increased wear.Do not re-use damaged or worn devices" but in all three complaint devices, the groove was found to be excessive damaged and worn out.Corrective action is not required at this time as the root cause of this complaint is deemed related to unintentional user error related because product ifu instructions state "always inspect the devices for damage or increased wear.Do not re-use damaged or worn devices." the complaints of a light flickering in rusch greenled handle: medium products cannot be confirmed.The customer returned the three actual complaint samples of rusch greenled handle and visual examination did not reveal any obvious defects or anomalies as the devices appear typical.Functional testing revealed that the handles are flickers when connected with blade.There is light flickering on the handle as reported in the complaint.The complaint cannot be confirmed because there were deep scratch marks noted on the internal locking mechanism of the handles and locking mechanism found to be damaged of all three handles.These marks reveal that the device have been used multiple times by the end user, and they are indicative of increased wear and grove is worn out.Product ifu instructions state "always inspect the devices for damage or increased wear.Do not re-use damaged or worn devices." the products were manufactured at the chandigarh site in june 2020.The device history record 200601 was reviewed and no issue that could have contributed to the reported failure was noted.The devices were manufactured according to the release specifications.Based on the functional testing performed on the devices it is found that these are not justified complaints as root cause of these complaints are deemed related to unintentional user error related because product ifu instructions state "always inspect the devices for damaged 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 flickers prior to use.It seems as if the blade can not be fixed properly, leading to the light flickering.".

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16536782
• MDR Text Key: 311571680
• Report Number: 8030121-2023-00006
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704711694
• UDI-Public: 14026704711694
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/10/2023

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: 200601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2023
• Initial Date FDA Received: 03/14/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2020
• 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