MAUDE Adverse Event Report: TELEFLEX MEDICAL USCH GREENLITE DISP MTL MILL 0; LARYNGOSCOPE, RIGID

Model Number IPN048378

Device Problem Break (1069)

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

Event Date 03/28/2022

Event Type  malfunction  

Event Description

It was reported "broken light pipe in bag prior to use and broken light pipe at time of use on second blade." clarifying information received from customer stated that there was no patient involvement when issue was observed.

Manufacturer Narrative

Qn# (b)(4).

Manufacturer Narrative

(b)(4).The customer returned one 004550000 rusch greenlite disposable metal miller 0 blade for investigation.The blade was returned in its original packaging.Visual inspection revealed that there was a crack in the clear plastic bottom of the light pipe.The manufacturing site was consulted for this complaint investigation.The site stated that this product is tested for light guide breakage and functionally tested during 300% inspection prior to shipping to the customer.The device history record of lot 1711401 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The complaint is confirmed.The blade was returned out of its original packaging.Vthat there was a crack in the clear plastic bottom of the light pipe.It was determined that this is not a manufacturing related issue.The probable root cause is likely related to shipping/storage of the device.The light pipe guide is made of pmma (polymethyl methacrylate) which can be broken under external impact during transit.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported "broken light pipe in bag prior to use and broken light pipe at time of use on second blade".Clarifying information received from customer stated that there was no patient involvement when issue was observed.

• Brand Name: USCH GREENLITE DISP MTL MILL 0
• 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: 14189219
• MDR Text Key: 290461183
• Report Number: 8030121-2022-00015
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026710625992
• UDI-Public: 14026710625992
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/30/2022
• Device Model Number: IPN048378
• Device Catalogue Number: 004550000
• Device Lot Number: 1711401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED