MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 4; LARYNGOSCOPE, RIGID

Catalog Number 004551004

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 08/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported "device was found broken in the packaging during a random checking of the bag that stays in the ambulance".No patient involvement reported.

Event Description

Customer reported "device was found broken in the packaging during a random checking of the bag that stays in the ambulance".No patient involvement reported.

Manufacturer Narrative

(b)(4).The sample was received and returned to the manufacturing site for evaluation.The manufacturing site reports a visual exam was performed and it was observed that the base of light guide is broken.It was also observed the spot welding joint was intact.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.The manufacturer also reports that the device is inspected prior to release thus it is confirmed that it left the manufacturing facility fully functional.It seems as though the device sustained unexplained physical damage.A root cause could not be determined.Due to an increase in complaints for breakage, a capa was opened to further investigate this issue.

• Brand Name: RUSCH GREENLITE DISP MTL MAC 4
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 9130452
• MDR Text Key: 189454058
• Report Number: 8030121-2019-00081
• 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: 09/06/2019

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: No Information
• Device Catalogue Number: 004551004
• Device Lot Number: 1905341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 10/25/2019
• Supplement Dates FDA Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1