MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 3; LARYNGOSCOPE, RIGID

Catalog Number 004551003

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported the plastic part of the light source broke off into the patient's mouth when the clinician lifted the patient's tongue.The broken pieces were removed safely from the patient's mouth and no patient injury or consequence was reported.The patient's condition was reported as "fine".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation and sent to the manufacturing site for investigation.A visual exam was performed and it was observed that the base of light guide is broken.The manufacturer 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.

Event Description

The customer reported the plastic part of the light source broke off into the patient's mouth when the clinician lifted the patient's tongue.The broken pieces were removed safely from the patient's mouth and no patient injury or consequence was reported.The patient's condition was reported as "fine".

• Brand Name: RUSCH GREENLITE DISP MTL MAC 3
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8826795
• MDR Text Key: 152211867
• Report Number: 8030121-2019-00059
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

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: Health Professional
• Device Catalogue Number: 004551003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/25/2019
• Supplement Dates Manufacturer Received: 08/30/2019
• Supplement Dates FDA Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.