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

Catalog Number 004550003

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 09/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported a piece of the plastic broke off into the patient's throat.The piece was retrieved from the patient, but it was reported to take an hour to retrieve.Patient reported to be fine.Additional information was requested, but not received at the time of this report.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

Customer reported a piece of the plastic broke off into the patient's throat.The piece was retrieved from the patient, but it was reported to take an hour to retrieve.Patient reported to be fine.Additional information was requested, but not received at the time of this report.

• Brand Name: RUSCH GREENLITE DISP MTL MILL 3
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 9199311
• MDR Text Key: 163003804
• Report Number: 8030121-2019-00101
• 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: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/08/2023
• Device Catalogue Number: 004550003
• Device Lot Number: 1901431
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 11/13/2019
• Supplement Dates FDA Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.
• Patient Outcome(s): Required Intervention