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

Catalog Number 0055501EU

Device Problem Optical Problem (3001)

Patient Problem No Patient Involvement (2645)

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the led light did not work prior to patient use.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation and sent to the manufacturing site for investigation.The manufacturing site reports that the cartridge was "responding red and green light when it had connected with the power source like charger with electricity".The manufacturing site also reports that it was observed that there was a thick formation inside of the inner cartridge indicating an incorrect sterilization or cleaning process.The device history record of lot of the sample received (190601) was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The manufacturing site reports the "failure cannot be justified as during investigation we noticed traces of chemical / disinfectant on the surface on the inner cartridges and definitely disinfectant / chemical had entered on the inner surface and there is possibility that due to chemical exposure internal electrical circuit of led has got fused.As per the ifu instructions the outer handle may be autoclaved or sterilized via steris or sterrad and the inner cartridge is not suitable for sterilization but during investigation we have traces the chemical agent layer on inner cartridge.

Event Description

It was reported the led light did not work prior to patient use.

• Brand Name: RUSCH TRULED HANDLE, MEDIUM, EUROPE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 10356203
• MDR Text Key: 201542166
• Report Number: 8030121-2020-00133
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/15/2020
• Device Catalogue Number: 0055501EU
• Device Lot Number: 190301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1