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

Catalog Number 004551004

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges "the plastic part detached".It was reported there were no clinical consequences for the patient as the device was not used on any patient.

Event Description

Customer complaint alleges "the plastic part detached".It was reported there were no clinical consequences for the patient as the device was not used on any patient.

Manufacturer Narrative

(b)(6).The sample was returned for evaluation.A visual exam was performed and it was found that the base of light guide is broken.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 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.

Event Description

Customer complaint alleges "the plastic part detached".It was reported there were no clinical consequences for the patient as the device was not used on any patient.

Manufacturer Narrative

Qn#(b)(4).Corrected data: concomitant medical products - device available for evaluation corrected to "no".Device evaluated by mfr - corrected to "not returned to manufacturer".Evaluation method corrected from "10" to "4114".Additional manufacturer narrative corrected to reflect that no actual sample was received.The customer returned photos; therefore, the investigation was performed on the photos, not the device.Investigation results remain the same.

• Brand Name: RUSCH GREENLITE DISP MTL MAC 4
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8483592
• MDR Text Key: 140930358
• Report Number: 8030121-2019-00035
• 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,Followup
• Report Date: 04/03/2019

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: No Information
• Device Expiration Date: 08/01/2023
• Device Catalogue Number: 004551004
• Device Lot Number: 1809341
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/07/2019
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 05/16/2019; 05/23/2019
• Supplement Dates FDA Received: 05/22/2019; 05/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.; NONE REPORTED.